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

February 2, 2024 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

Effect of Chemotherapy With Paclitaxel and Cisplatin on Development Dysgeusia in Non-small Cell Lung Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Lung cancer is the leading cause of death from malignancies in our country. It was recently reported to induce 11.5% of cancer deaths in Mexico, with a rate of 6.5 per 100 000 people.

Non-Small Cell Lung Cancer (NSCLC) accounts for 80% of all lung cancer cases. Less than 20% has resectable disease and in the National Cancer Institute of Mexico exclusively less than 2%, representing chemotherapy the standard of care in these patients.

One of the most widely used drug combinations is paclitaxel-cisplatin. It has been reported a prevalence of malnutrition in 60 to 79% in this type of cancer, being the major contributor to morbidity and mortality. The etiology resides both in the systemic effects of the tumor and toxic effects of treatment as low levels hematologic, nausea, vomiting, mucositis, anorexia, dysgeusia, among others.

Weight loss has a strong impact on the response to chemotherapy, radiotherapy and surgery, as well as increased toxic effects impacting the discontinuation of treatment and is considered an independent predictor of survival for most patients with NSCLC. Is estimated that over 20% of cancer patients the cause of death are inanition effects.

Among the most frequent symptoms in advanced unresectable cancer or its treatment that may affect food intake and hence nutritional status, are the early satiety and dysgeusia (61% and 46% respectively). As are difficult to change early satiety, dysgeusia is a field for selecting strategies in its management.

The dysgeusia is defined as a change in taste that can manifest as a distortion of taste, lack of taste (ageusia), decreased sensitivity of perception (hypogeusia) or increased sensitivity to some or all flavors (hypergeusia).

The development of dysgeusia have clinical significance in the etiology of cancer anorexia because it can affect eating habits and contribute to weight loss or malnutrition and consequently affect the quality of life.

The chemotherapy may contribute to dysgeusia. It has reported a prevalence of 56.3% of Dysgeusia in cancer patients under this type of treatment. As well, zinc deficiency has been associated with the hypogeusia, this metal to be involved at various levels in the physiology of the role of taste at various levels of cell several organization.

Several studies have linked consumption dysgeusia with energy and macronutrients, weight loss, lack of appetite and early satiety.

The type of tumor, stage, chemotherapy regimen and serum zinc levels are associated with dysgeusia, but the exact mechanism underlining these disturbances are not known at totality. No known if chemotherapy or before this is presented dysgeusia. In addition there are few studies in this area and with methodological weaknesses, among which include heterogeneous population (patients with a diagnosis of malignancy of breast, lung, prostate, multiple myeloma and lymphoma), different patterns of treatment(different chemotherapy drugs, radiotherapy schedules and combination of both forms of measurement of dysgeusia, besides the absence of dysgeusia baseline evaluation before chemotherapy to establish a causal association between chemotherapy and taste alteration.

Also, is unknown if dysgeusia impact on body composition determined by bioelectrical impedance, phase angle in and consumption of micronutrients (iron, sodium, zinc, B6, B12).

That's why is necessary to continue studying this phenomenon to develop a better understanding of the nature, frequency, severity and duration of dysgeusia in patients with advanced lung cancer, the role that zinc exerts in its development and its impact on consumption food, anthropometric parameters and quality of life in such patients before and after chemotherapy in the same regimen of chemotherapy.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico city, Distrito Federal, Mexico, 14080
        • National Cancer Institute of Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline in threshold of perception at 6 weeks
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.
Change from Baseline in threshold of perception at 6 weeks
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.
Change from Baseline in threshold of perception at 6 weeks
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.
Change from Baseline in threshold of perception at 6 weeks
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.
Change from Baseline in threshold of perception at 6 weeks
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.
Change from Baseline in threshold of perception at 6 weeks
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)
pre - post chemotherapy (6 weeks)
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.
pre - post chemotherapy (6 weeks)
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
pre - post chemotherapy (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BODY COMPOSITION
Time Frame: Change from Baseline in perception and recognition thresholds at 6 weeks
fat mass and lean body mass pre-post chemotherapy
Change from Baseline in perception and recognition thresholds at 6 weeks
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
Change from Baseline in threshold of perception and recognition at 6 weeks
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).
descriptive values before chemotherapy
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
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
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
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
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.
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
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
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
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.
participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks
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.
time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar G Arrieta, MD M Sc, Mexico. Nacional Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimated)

February 28, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECPCDLC2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe