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

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:

MedlinePlus related topics: Cancer Lung Cancer Taste and Smell Disorders

Drug Information available for: Cisplatin Paclitaxel

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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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 Carcinoma, Non-Small-Cell Lung Dysgeusia Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Respiratory Tract Diseases Respiratory Tract Neoplasms Sensation Disorders	Signs and Symptoms Taste Disorders Thoracic Neoplasms Cisplatin Paclitaxel Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Phytogenic Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators

ClinicalTrials.gov processed this record on March 01, 2015