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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04543175
Other study ID # DI/13/111/04/0249
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date January 1, 2019

Study information

Verified date September 2020
Source Hospital General de Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date January 1, 2019
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Mexico Hospital General de México Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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