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

NCT01540045 | Completed Results DMC

• 1 other identifier: ECPCDLC2012
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Non-Small Cell Lung Cancer; Dysgeusia; Antineoplastic Combined Chemotherapy Protocols; Paclitaxel; Cisplatin

Outcome Measures

Primary Outcomes (9)

• Dysgeusia (UMAMI Perception)

  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.

  Change from Baseline in threshold of perception at 6 weeks

• Dysgeusia (UMAMI Recognition)

  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.

  Change from Baseline in threshold of perception at 6 weeks

• Dysgeusia (SWEET Perception)

  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.

  Change from Baseline in threshold of perception at 6 weeks

• Dysgeusia (SWEET Recognition)

  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.

  Change from Baseline in threshold of perception at 6 weeks

• Dysgeusia (BITTER Perception)

  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.

  Change from Baseline in threshold of perception at 6 weeks

• Dysgeusia (BITTER Recognition)

  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.

  Change from Baseline in threshold of perception at 6 weeks

• Dysgeusia (UMAMI Dilutions Dichotomized)

  We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)

  pre - post chemotherapy (6 weeks)

• Dysgeusia (SWEET Dilutions Dichotomized)

  We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.

  pre - post chemotherapy (6 weeks)

• Dysgeusia (BITTER Dilutions Dichotomized)

  We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes

  pre - post chemotherapy (6 weeks)

Secondary Outcomes (9)

• BODY COMPOSITION

  Change from Baseline in perception and recognition thresholds at 6 weeks

• Body Mass Index

  Change from Baseline in threshold of perception and recognition at 6 weeks

• Subjective Global Assessment

  descriptive values before chemotherapy

• PROTEIN AND FAT Consumption

  participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks

• IRON Consumption

  participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

National Cancer Institute of Mexico

Mexico City, Mexico City, 14080, Mexico

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Dysgeusia; Taste Disorders; Lung Neoplasms; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No analysis of serum zinc was performed and a small number of subjects analyzed.

Results Point of Contact

• Title: Dr. Oscar Arrieta
• Organization: Instituto Nacional de Cancerología de México

ogarrieta@gmail.com

5628-0400

Study Officials

• Oscar G Arrieta, MD M Sc

  Mexico. Nacional Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Of the Thoracic Oncology Clinic. SNI II

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: February 28, 2012
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: February 28, 2024
• Results First Posted: March 18, 2015

Record last verified: 2024-02

Locations

ME (1)