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Taste Disorders and Their Relation to BMI, FFQ, and EORTC QLQ-BR23 in Breast Cancer Patients During Chemotherapy.

Sponsor
Hospital General de Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT04543175
Collaborator
(none)
106
Enrollment
1
Location
24
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Taste disorders in cancer patients during chemotherapy could be consider as multifactorial disease, it is related with changes of food consumption. Approximately 36-69% of the patients under chemotherapy suffer oral toxicity or dysgeusia

A prospective case- only observational study was conducted in patients of the Hospital General de México for two years. A self-reported taste survey was used, and patients scored their results in a Likert scale.

Condition or Disease Intervention/Treatment Phase
  • Other: Taste disorder´s test

Study Design

Study Type:
Observational
Actual Enrollment :
106 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Taste Disorders and Their Relation to Body Mass Index, Food Frequency Questionnaire and Quality of Life in Breast Cancer Patients During Chemotherapy.
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Chemotherapy breast cancer patients

Newly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy with the following drugs (Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel were followed until they complete four cycles of chemotherapy.

Other: Taste disorder´s test
Each patient performed their own test placing three drops with a disposable dropper from each bottle into the center of the tongue for whole-mouth testing.
Other Names:
  • Taste disorders

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of taste disorders and perception of the four basic flavors [21 days]

      to assess the prevalence of taste alterations perception of the four basic flavors (sweet, salty, bitter and acidic) in newly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.
    Exclusión Criteria:
    • No smokers Infections in oral cavity Acute respiratory diseases Gastro- oesophageal reflux disease Other types of cancer.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital General de México Mexico City Mexico 06726

    Sponsors and Collaborators

    • Hospital General de Mexico

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Vanessa Fuchs Tarlovsky, Principal investigator, Hospital General de Mexico
    ClinicalTrials.gov Identifier:
    NCT04543175
    Other Study ID Numbers:
    • DI/13/111/04/0249
    First Posted:
    Sep 10, 2020
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Taste Disorders
    Dysgeusia
    Ageusia

    Study Results

    No Results Posted as of Sep 10, 2020