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

Colorectal adenocarcinoma patients followed through their chemotherapy for assessing oral mucositis manifestations.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000339257
Acronym
5FU-OM study
Enrollment
25
Registered
2009-05-25
Start date
2007-12-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main purpose of the trial is to gather information on occurrence, features and severity of oral mucositis related to a 5-FU and folinic acid chemotherapy protocol applied to a cohort of patients with a solid malignant tumor - colorectal adenocarcinoma.

Interventions

Observational study on the frequency and severity of chemotherapy induced oral mucositis manifestations in a cohort of patients with colorectal cancer treated with a fluorouracil plus folinic acid chemotherapy, during the whole chemotherapy protocol, i.e. 7 months. Chemotherapy induced oral mucositis is characterized by a range of symptoms varying from mild burning sensation up to extensive ulcerations that preclude patients from feeding and drinking, demanding hospitalization. The patients to b

Observational study on the frequency and severity of chemotherapy induced oral mucositis manifestations in a cohort of patients with colorectal cancer treated with a fluorouracil plus folinic acid chemotherapy, during the whole chemotherapy protocol, i.e. 7 months. Chemotherapy induced oral mucositis is characterized by a range of symptoms varying from mild burning sensation up to extensive ulcerations that preclude patients from feeding and drinking, demanding hospitalization. The patients to be included in this study will be seen at an ambulatory environment of a specialized oncology center, already submitted to surgical treatment of their colon adenocarcinoma and driven to chemotherapy intervention.

Sponsors

Sao Paulo University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026