NCT04543175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 2, 2020

Last Update Submit

September 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of taste disorders and perception of the four basic flavors

    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

    21 days

Study Arms (1)

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

Interventions

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.

Also known as: Taste disorders
Chemotherapy breast cancer patients

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients of Oncology ward in Hospital General de Mexico between 20 and 60 years old with newly diagnosed breast cancer. and chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.

You may qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de México

Mexico City, 06726, Mexico

Location

MeSH Terms

Conditions

Breast NeoplasmsTaste DisordersDysgeusiaAgeusia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 10, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations