Patients on fluorouracil and folinic acid chemotherapy: a cohort study focused on oral mucositis.

Not Applicable

Active, not recruiting

• Conditions: Chemotherapy induced oral mucositis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12609000339257
• Lead Sponsor: Sao Paulo University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Patients surgically treated of a colorectal adenocarcinoma and elected to receive chemotherapy composed of fluorouracil and folinic acid according to a bolus delivering regimen

Exclusion Criteria

Patients that do not match the inclusion criteria will not be eligible for the study. Adittionally patients that suffer any modification in their chemotherapy protocol during the course of the trial will be also excluded.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence and frequency of oral mucositis in all chemotherapy cycles applied to the patient's cohort followed in the trial, to be assessed through clinical examination carried out by a health professional and visual analogue scales to evaluate symptoms like xerostomia and pain.[One time a month, after the chemotherapy infusion period, i.e., all patients will be examined a week after the chemotherapy infusion which takes five consecutive days in a week. The chemotherapy protocol extends through six months with one infusion week per month. Patients will be followed through seven months and will be examined once a month.]

Secondary Outcome Measures

Name	Time	Method
Influence of medical condition over oral mucositis manifestation. This aspect will be evaluated according to data recovered at patients clinical evaluation and the frequency and severity of oral mucositis manifestations in each cycle.[one time a month, after the chemotherapy infusion period, assessed through a clinical evaluation performed by a health professional. Chemotherapy protocol applied in this study takes six months with one infusion week per month. Patients will be followed through seven months with at least one examination per month.]