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

This study is currently recruiting participants.
Verified February 2012 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodriguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01540045
First received: January 13, 2012
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Non-Small Cell Lung Cancer
Dysgeusia
Taste Disorders
Lung Neoplasms
Small Cell Lung Carcinoma

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

Primary Outcome Measures:
  • dysgeusia [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    describe the threshold of perception and recognition of 3 basic tastes (sweet, bitter and umami) with 5 dilutions with different concentrations


Secondary Outcome Measures:
  • Body composition [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    fat mass, fat-free mass and phase angle by bioelectrical impedance

  • Body Mass Index [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    using the formula kg/m2

  • weight loss [ Time Frame: from 6 month ago to baseline ] [ Designated as safety issue: Yes ]
    asking the patient or or looking into medical history

  • Subjective Global Assessment [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    validated questionnaire to identify patients with malnutrition or risk of malnutrition

  • proportion of Anorexia [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    by section related to nutrition from FAACT.

  • energy and nutrimental consumption [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    by questionarie SNUT

  • quality o f life [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    bye EORT questionarie


Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Patients over 18 years old with INCan histopathological diagnosis of Lung Cancer Stage III or IV
  • ECOG score ≤ 2
  • Candidates for first-line chemotherapy based 1 st Paclitaxel / cisplatin 200 mg/m2 and 75 every 3 weeks
  • Signed informed consent (and ethical scientific committee No. (010/023 (IMO) (CB/618

Exclusion Criteria:

  • Patients who withdraw their consent and not want to continue with the evaluation of the study
  • Common cold or hay fever, recent dental procedure, evidence of gingival inflammation or infection or oral mucosa
  • People diagnosed with epilepsy or some other neurological disorders associated
  • Concomitant radiotherapy in head and neck.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540045

Contacts
Contact: Oscar G Arrieta, MD M Sc 56 28 04 00 ext 353 ogar@unam.mx
Contact: Karla P Sánchez, M Sc. 5528880264 kpao82@hotmail.com

Locations
Mexico
National Cancer Institute of Mexico Recruiting
Mexico city, Distrito Federal, Mexico, 14080
Contact: Oscar G Arrieta, MD M Sc.     56 28 04 00 ext 353     ogar@unam.mx    
Contact: Karla P Sánchez, M Sc.     5528880264     kpao82@hotmail.com    
Principal Investigator: Oscar G Arrieta, Oncologist            
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Oscar G Arrieta, MD M Sc Mexico. Nacional Cancer Institute
  More Information

Publications:

Responsible Party: Oscar Gerardo Arrieta Rodriguez MD, SNI II, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01540045     History of Changes
Other Study ID Numbers: ECPCDLC2012
Study First Received: January 13, 2012
Last Updated: February 22, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Non-Small Cell Lung Cancer
Dysgeusia
Antineoplastic Combined Chemotherapy Protocols
Paclitaxel
Cisplatin

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Dysgeusia
Taste Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 23, 2013