Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000339257
Ethics application status
Approved
Date submitted
24/01/2009
Date registered
25/05/2009
Date last updated
25/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patients on fluorouracil and folinic acid chemotherapy: a cohort study focused on oral mucositis.
Scientific title
Colorectal adenocarcinoma patients followed through their chemotherapy for assessing oral mucositis manifestations.
Universal Trial Number (UTN)
Trial acronym
5FU-OM study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy induced oral mucositis 4232 0
Condition category
Condition code
Oral and Gastrointestinal 4453 4453 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 236626 0
Not applicable
Comparator / control treatment
Observational study with no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5334 0
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.
Timepoint [1] 5334 0
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 [1] 8966 0
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.
Timepoint [1] 8966 0
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.

Eligibility
Key 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
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 1547 0
Brazil
State/province [1] 1547 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 5004 0
University
Name [1] 5004 0
Sao Paulo University
Country [1] 5004 0
Brazil
Primary sponsor type
University
Name
Sao Paulo University
Address
Av Prof Lineu Prestes, 2227 Postal Code: 05580-900
Country
Brazil
Secondary sponsor category [1] 3973 0
Commercial sector/Industry
Name [1] 3973 0
Oncoclin
Address [1] 3973 0
R Barao do Triunfo, 1539
CEP 04602-006
Country [1] 3973 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6464 0
Dentistry School, Sao Paulo University
Ethics committee address [1] 6464 0
Ethics committee country [1] 6464 0
Brazil
Date submitted for ethics approval [1] 6464 0
Approval date [1] 6464 0
22/10/2007
Ethics approval number [1] 6464 0
179/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29216 0
Address 29216 0
Country 29216 0
Phone 29216 0
Fax 29216 0
Email 29216 0
Contact person for public queries
Name 12463 0
Liane Marmo Gambirazi
Address 12463 0
R Dr Neto de Araújo, 320 cjto 1104
CEP 04111-001
Country 12463 0
Brazil
Phone 12463 0
+55 11 50842605
Fax 12463 0
+55 11 30917883
Email 12463 0
lianemg@ig.com.br
Contact person for scientific queries
Name 3391 0
Norberto Nobuo Sugaya
Address 3391 0
Av Prof Lineu Prestes, 2227 Postal Code: 05580-900
Country 3391 0
Brazil
Phone 3391 0
+55 11 30917883
Fax 3391 0
+55 11 30917883
Email 3391 0
nnsugaya@usp.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.