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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

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 (h
Sponsor: Instituto Nacional de Cancerologia de Mexico

Current Primary Outcome:

  • 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.

  • 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.

  • Dysgeusia

    Original Primary Outcome: dysgeusia [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ]

    describe the threshold of perception and recognition of 3 basic tastes (sweet, bitter and umami) with 5 dilutions with different concentrations


    Current Secondary Outcome:

    • BODY COMPOSITION [ Time Frame: Change from Baseline in perception and recognition thresholds at 6 weeks ]
      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 ]
      Body mass index, using the formula kg/m^2
    • 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).
    • 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
    • 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
    • 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.
    • 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
    • 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.
    • 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.



    Original Secondary Outcome:

    • BODY COMPOSITION [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ]
      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 ]
      using the formula kg/m2
    • weight loss [ Time Frame: from 6 month ago to baseline ]
      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 ]
      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 ]
      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 ]
      by questionarie SNUT
    • quality o f life [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ]
      bye EORT questionarie


    Information By: Instituto Nacional de Cancerologia de Mexico

    Dates:
    Date Received: January 13, 2012
    Date Started: December 2010
    Date Completion:
    Last Updated: March 6, 2015
    Last Verified: March 2015