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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01540045
First received: January 13, 2012
Last updated: March 6, 2015
Last verified: March 2015
  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:


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

Primary Outcome Measures:
  • Dysgeusia (UMAMI Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Dysgeusia (UMAMI Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Dysgeusia (SWEET Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Dysgeusia (SWEET Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Dysgeusia (BITTER Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Dysgeusia (BITTER Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Dysgeusia (UMAMI Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ] [ Designated as safety issue: Yes ]
    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)

  • Dysgeusia (SWEET Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ] [ Designated as safety issue: Yes ]
    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.

  • Dysgeusia (BITTER Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ] [ Designated as safety issue: Yes ]
    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes


Secondary Outcome Measures:
  • BODY COMPOSITION [ Time Frame: Change from Baseline in perception and recognition thresholds at 6 weeks ] [ Designated as safety issue: Yes ]
    fat mass and lean body mass pre-post chemotherapy

  • Body Mass Index [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ] [ Designated as safety issue: Yes ]
    Body mass index, using the formula kg/m^2

  • Subjective Global Assessment [ Time Frame: descriptive values before chemotherapy ] [ Designated as safety issue: Yes ]
    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).

  • PROTEIN AND FAT Consumption [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ] [ Designated as safety issue: Yes ]
    energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy

  • IRON Consumption [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ] [ Designated as safety issue: Yes ]
    IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy

  • Quality o f Life [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    comparison of patients who increased or decreased their sensibility to the PT of umami taste

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 40
Study Start Date: December 2010
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

Locations
Mexico
National Cancer Institute of Mexico
Mexico city, Distrito Federal, Mexico, 14080
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 Rodríguez MD, Head Of the Thoracic Oncology Clinic. 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
Results First Received: July 23, 2013
Last Updated: March 6, 2015
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:
Carcinoma, Non-Small-Cell Lung
Dysgeusia
Lung Neoplasms
Small Cell Lung Carcinoma
Taste Disorders
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
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 July 05, 2015