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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruit patients since September 2010 to July 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Pre-chemotherapy Patientes =40 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

Participant Flow:   Overall Study
    Pre-chemotherapy Patientes =40
STARTED   40 
COMPLETED   40 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Pre-chemotherapy Patientes =40 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

Baseline Measures
   Pre-chemotherapy Patientes =40 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (15) 
Gender 
[Units: Participants]
 
Female   20 
Male   20 
Region of Enrollment 
[Units: Participants]
 
Mexico   40 


  Outcome Measures

1.  Primary:   Dysgeusia (UMAMI Perception)   [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

2.  Primary:   Dysgeusia (UMAMI Recognition)   [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

3.  Primary:   Dysgeusia (SWEET Perception)   [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

4.  Primary:   Dysgeusia (SWEET Recognition)   [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

5.  Primary:   Dysgeusia (BITTER Perception)   [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

6.  Primary:   Dysgeusia (BITTER Recognition)   [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

7.  Primary:   Dysgeusia (UMAMI Dilutions Dichotomized)   [ Time Frame: pre - post chemotherapy (6 weeks) ]

8.  Primary:   Dysgeusia (SWEET Dilutions Dichotomized)   [ Time Frame: pre - post chemotherapy (6 weeks) ]

9.  Primary:   Dysgeusia (BITTER Dilutions Dichotomized)   [ Time Frame: pre - post chemotherapy (6 weeks) ]

10.  Secondary:   BODY COMPOSITION   [ Time Frame: Change from Baseline in perception and recognition thresholds at 6 weeks ]

11.  Secondary:   Body Mass Index   [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ]

12.  Secondary:   Subjective Global Assessment   [ Time Frame: descriptive values before chemotherapy ]

13.  Secondary:   PROTEIN AND FAT Consumption   [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]

14.  Secondary:   IRON Consumption   [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]

15.  Secondary:   Quality o f Life   [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]

16.  Secondary:   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 ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No analysis of serum zinc was performed and a small number of subjects analyzed.


  More Information

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
e-mail: ogarrieta@gmail.com


Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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