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Trial record 3 of 85 for:    Taste Disorders AND perception

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

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ClinicalTrials.gov Identifier: NCT01540045
Recruitment Status : Completed
First Posted : February 28, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Tracking Information
First Submitted Date January 13, 2012
First Posted Date February 28, 2012
Results First Submitted Date July 23, 2013
Results First Posted Date March 18, 2015
Last Update Posted Date March 18, 2015
Study Start Date December 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2015)
  • 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 (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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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.
  • 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
Original Primary Outcome Measures
 (submitted: February 22, 2012)
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
Change History Complete list of historical versions of study NCT01540045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 6, 2015)
  • 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 Measures
 (submitted: February 22, 2012)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer
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 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Non-Small Cell Lung Cancer
  • Dysgeusia
  • Taste Disorders
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2015)
40
Original Estimated Enrollment
 (submitted: February 22, 2012)
60
Actual Study Completion Date May 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT01540045
Other Study ID Numbers ECPCDLC2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
Study Sponsor Instituto Nacional de Cancerologia de Mexico
Collaborators Not Provided
Investigators
Principal Investigator: Oscar G Arrieta, MD M Sc Mexico. Nacional Cancer Institute
PRS Account Instituto Nacional de Cancerologia de Mexico
Verification Date March 2015