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Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01540045
Recruitment Status : Completed
First Posted : February 28, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Non-Small Cell Lung Cancer
Dysgeusia
Taste Disorders
Lung Neoplasms
Small Cell Lung Carcinoma
Enrollment 40
Recruitment Details We recruit patients since September 2010 to July 2012
Pre-assignment Details We invited to participate 40 patients who completed their baseline evaluation and their follow up after two cycles of chemotherapy using paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). The main reason of exclusion was death followed by not returning to the institution.
Arm/Group Title Pre-chemotherapy Patientes =40
Hide Arm/Group Description Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title Pre-chemotherapy Patientes =40
Hide Arm/Group Description Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
We invited to participate 72 patients with NSCLC newly diagnosed, but only 40 patients completed their baseline evaluation and their follow up after two cycles of chemotherapy using paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). The main reason of exclusion was death followed by not returning to the institution.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
55.5  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
20
  50.0%
Male
20
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 40 participants
40
1.Primary Outcome
Title Dysgeusia (UMAMI Perception)
Hide Description

Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations.

The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time Frame Change from Baseline in threshold of perception at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Median (Full Range)
Unit of Measure: μmol/ml
.3
(.3 to 3.3)
.3
(.3 to 2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Dysgeusia (UMAMI Recognition)
Hide Description

Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations.

The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time Frame Change from Baseline in threshold of perception at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Median (Full Range)
Unit of Measure: μmol/ml
2.4
(.3 to 3.3)
1.5
(.3 to 3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Dysgeusia (SWEET Perception)
Hide Description

Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations.

The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time Frame Change from Baseline in threshold of perception at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Median (Full Range)
Unit of Measure: μmol/ml
3.5
(3.5 to 18.5)
3.5
(3.5 to 18.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.312
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Dysgeusia (SWEET Recognition)
Hide Description

Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations.

The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time Frame Change from Baseline in threshold of perception at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Median (Full Range)
Unit of Measure: μmol/ml
15.5
(3.5 to 18.5)
12.5
(3.5 to 18.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.608
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Primary Outcome
Title Dysgeusia (BITTER Perception)
Hide Description

Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations.

The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time Frame Change from Baseline in threshold of perception at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Mean (Full Range)
Unit of Measure: μmol/ml
97
(91 to 121)
91
(91 to 121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Primary Outcome
Title Dysgeusia (BITTER Recognition)
Hide Description

Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations.

The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time Frame Change from Baseline in threshold of perception at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Median (Full Range)
Unit of Measure: μmol/ml
115
(91 to 121)
109
(91 to 121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.402
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Primary Outcome
Title Dysgeusia (UMAMI Dilutions Dichotomized)
Hide Description We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)
Time Frame pre - post chemotherapy (6 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: participants
UMAMI 0.3 – 1.5 μmol/ml 31 36
UMAMI > 1.5 μmol/ml 9 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
8.Primary Outcome
Title Dysgeusia (SWEET Dilutions Dichotomized)
Hide Description We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.
Time Frame pre - post chemotherapy (6 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
patients with high or low sensibility to umami, bitter and sweet tastes pre-chemotherapy
patients with high or low sensibility to umami, bitter and sweet tastes post-chemotherapy
Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: participants
SWEET 3.5 – 9.5 μmol/ml 26 33
SWEET > 9.5 μmol/ml 14 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
9.Primary Outcome
Title Dysgeusia (BITTER Dilutions Dichotomized)
Hide Description We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes
Time Frame pre - post chemotherapy (6 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
measurement pre-chemotherapy
measurement post-chemotherapy
Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: participants
BITTER 91 – 103 μmol/ml 26 35
BITTER > 109 μmol/ml 14 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
10.Secondary Outcome
Title BODY COMPOSITION
Hide Description fat mass and lean body mass pre-post chemotherapy
Time Frame Change from Baseline in perception and recognition thresholds at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
body composition pre-chemotherapy
body composition post chemotherapy
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: kg
FAT MASS (kg) 20.09  (7.7) 19.67  (6.5)
LEAN BODY MASS (kg) 41.79  (13) 41.26  (11.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.671
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.694
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Body Mass Index
Hide Description Body mass index, using the formula kg/m^2
Time Frame Change from Baseline in threshold of perception and recognition at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patients
Hide Arm/Group Description:
body mass index pre-chemotherapty
body mass index post chemotherapy
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: kg/m^2
24.5  (4) 24.1  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patients
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Subjective Global Assessment
Hide Description validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).
Time Frame descriptive values before chemotherapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-chemotherapy Patientes Post-chemotherapy Patientes
Hide Arm/Group Description:
Subjective Global Assessment pre-chemotherapy
Subjective Global Assessment post chemotherapy
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
SGA A 26 23
SGA B & C 14 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-chemotherapy Patientes, Post-chemotherapy Patientes
Comments Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.607
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
13.Secondary Outcome
Title PROTEIN AND FAT Consumption
Hide Description energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy
Time Frame participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ≥ Sweet Perception Thresholds After Chemotherapy < Sweet Perception Thresholds After Chemotherapy
Hide Arm/Group Description:
patient with more sensibility to perceive sweet taste from food
patient with less sensibility to perceive sweet taste from food
Overall Number of Participants Analyzed 29 11
Mean (Standard Deviation)
Unit of Measure: gr
proteins 59.12  (32.7) 91.07  (33.1)
animal proteins 28.2  (14) 49.29  (18.5)
fat 60.1  (26.2) 91.77  (31.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ≥ Sweet Perception Thresholds After Chemotherapy, < Sweet Perception Thresholds After Chemotherapy
Comments protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to < Sweet perception thresholds after chemotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ≥ Sweet Perception Thresholds After Chemotherapy, < Sweet Perception Thresholds After Chemotherapy
Comments animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ≥ Sweet Perception Thresholds After Chemotherapy, < Sweet Perception Thresholds After Chemotherapy
Comments FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title IRON Consumption
Hide Description IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy
Time Frame participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ≥ Sweet Perception Thresholds After Chemotherapy < Sweet Perception Thresholds After Chemotherapy
Hide Arm/Group Description:
IRON CONSUMPTION ≥ Sweet perception thresholds after chemotherapy
IRON CONSUMPTION < Sweet perception thresholds after chemotherapy
Overall Number of Participants Analyzed 29 11
Mean (Standard Deviation)
Unit of Measure: mg
10.8  (7.5) 16.11  (6.3)
15.Secondary Outcome
Title Quality o f Life
Hide Description The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.
Time Frame participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HRQL Pre-chemotherapy HRQL Post-chemotherapy
Hide Arm/Group Description:
Score of scale HRQL EORTC
Score of scale HRQL EORTC
Overall Number of Participants Analyzed 40 40
Median (Full Range)
Unit of Measure: Scores on a scale
Global status
58.33
(0 to 100)
66.67
(0 to 100)
Role functioning
66.67
(0 to 100)
83.33
(0 to 100)
Emotional functioning
66.67
(0 to 100)
91.67
(0 to 100)
Fatigue
38.8
(0 to 100)
22.22
(0 to 100)
Appetite loss
33.33
(0 to 100)
0
(0 to 100)
Constipation
33.33
(0 to 100)
0
(0 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HRQL Pre-chemotherapy, HRQL Post-chemotherapy
Comments change in status global of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.889
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HRQL Pre-chemotherapy, HRQL Post-chemotherapy
Comments change in functional role of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.293
Comments clinically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HRQL Pre-chemotherapy, HRQL Post-chemotherapy
Comments change in emotional functioning of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HRQL Pre-chemotherapy, HRQL Post-chemotherapy
Comments change in fatigue scale of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments clinically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection HRQL Pre-chemotherapy, HRQL Post-chemotherapy
Comments change in appetite loss of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.595
Comments clinically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection HRQL Pre-chemotherapy, HRQL Post-chemotherapy
Comments change in constipation scale of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments clinically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Albumin After 2 Cycles of Chemotherapy
Hide Description comparison of patients who increased or decreased their sensibility to the PT of umami taste
Time Frame participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title > or = Umami Perception Thresholds < Umami Perception Thresholds
Hide Arm/Group Description:

patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(> UPT) = more sensibility to umami perception

patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(< UPT) = less sensibility to umami perception

Overall Number of Participants Analyzed 34 6
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.4  (0.11) 0.28  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection > or = Umami Perception Thresholds, < Umami Perception Thresholds
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)
Hide Description comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.
Time Frame participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title > or = Umami Perception Thresholds < Umami Perception Thresholds
Hide Arm/Group Description:

peripheral neuropathy in patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(> UPT) = more sensibility to umami perception

peripheral neuropathy patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(< UPT) = less sensibility to umami perception

Overall Number of Participants Analyzed 30 6
Median (Full Range)
Unit of Measure: Units on a scale
33.33
(0 to 100)
16.66
(0 to 66.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection > or = Umami Perception Thresholds, < Umami Perception Thresholds
Comments change in peripheral neuropathy scale of quality of life between > ó = compared to < umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.240
Comments clinically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
18.Secondary Outcome
Title Global Status of Quality of Life (C-30,LC13 EORTC)
Hide Description

differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste.

score of scale 0-100, a higher score represents better overall state.

Time Frame time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title < or = Umami Recognition Thresholds > Umami Recognition Thresholds
Hide Arm/Group Description:
quality of life scales in patient with more or the same sensibility to recognize the umami taste
quality of life scales in patient with more or the same sensibility to recognize the umami taste
Overall Number of Participants Analyzed 20 9
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
75
(1.66 to 99.58)
66.67
(8.33 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection < or = Umami Recognition Thresholds, > Umami Recognition Thresholds
Comments change in status global of quality of life between > ó = compared to < umami recognition threshold after chemotherapy by EORT questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and/or Other [non-serious] adverse events were not collected/assessed for this observational study
 
Arm/Group Title LUNG CANCER PATIENTS
Hide Arm/Group Description any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational
All-Cause Mortality
LUNG CANCER PATIENTS
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LUNG CANCER PATIENTS
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LUNG CANCER PATIENTS
Affected / at Risk (%)
Total   0/0 
No analysis of serum zinc was performed and a small number of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Oscar Arrieta
Organization: Instituto Nacional de Cancerología de México
Phone: 5628-0400 ext 832
Publications of Results:
Other Publications:
Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01540045     History of Changes
Other Study ID Numbers: ECPCDLC2012
First Submitted: January 13, 2012
First Posted: February 28, 2012
Results First Submitted: July 23, 2013
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015