Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer
This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540045
First Posted: February 28, 2012
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight loss and malnutrition, which leads to a prognostic impact in a lower patient response to chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects, impacting treatment discontinuation and therefore, morbidity and survival of patients. The objective of this study is to describe the threshold of perception and recognition of basic tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy and after the second cycle, and analyze the effect in the developement of dysgeusia, as well as the association between these and the nutritional status and quality of life.
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Non-Small Cell Lung Cancer
Dysgeusia
Taste Disorders
Lung Neoplasms
Small Cell Lung Carcinoma
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| Study Type: |
Observational
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| Study Design: |
Observational Model: Cohort
Time Perspective: Prospective |
| Official Title: |
Effect of Chemotherapy With Paclitaxel and Cisplatin on Development Dysgeusia in Non-small Cell Lung Cancer Patients |
Primary Outcome Measures:
- Dysgeusia (UMAMI Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]
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.
- Dysgeusia (UMAMI Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]
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.
- Dysgeusia (SWEET Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]
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.
- Dysgeusia (SWEET Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]
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.
- Dysgeusia (BITTER Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]
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.
- Dysgeusia (BITTER Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]
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.
- Dysgeusia (UMAMI Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ]
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)
- Dysgeusia (SWEET Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ]
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.
- Dysgeusia (BITTER Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ]
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes
Secondary Outcome Measures:
- BODY COMPOSITION [ Time Frame: Change from Baseline in perception and recognition thresholds at 6 weeks ]
fat mass and lean body mass pre-post chemotherapy
- Body Mass Index [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ]
Body mass index, using the formula kg/m^2
- Subjective Global Assessment [ Time Frame: descriptive values before chemotherapy ]
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).
- PROTEIN AND FAT Consumption [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy
- IRON Consumption [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy
- Quality o f Life [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
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.
- Change From Baseline in Albumin After 2 Cycles of Chemotherapy [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
comparison of patients who increased or decreased their sensibility to the PT of umami taste
- Peripheral Neuropathy (QLQ-C30 Version 3, EORTC) [ Time Frame: participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks ]
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.
- Global Status of Quality of Life (C-30,LC13 EORTC) [ Time Frame: time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks ]
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.
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| Enrollment: |
40 |
| Study Start Date: |
December 2010 |
| Study Completion Date: |
May 2012 |
| Primary Completion Date: |
December 2011 (Final data collection date for primary outcome measure) |
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BASELINE
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
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