- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00383409
Multivitamins do Not Improve Radiation Therapy Related Fatigue
October 2, 2006 updated by: Faculdade de Medicina do ABC
Multivitamins do Not Improve Radiation Therapy Related Fatigue: Results of a Double-Blind Randomized Cross-Over Trial
Multivitamins (MVi) are broadly used by cancer patients to improve overall health and energy.
Fatigue is a common symptom in cancer patients including those receiving radiation therapy.
We conducted a trial of MVi versus placebo in patients with breast cancer (BC) undergoing radiation therapy (Rxt) to evaluate if MVi would affect fatigue and quality of life.
We randomized patients at the beginning of Rxt treatment to either placebo or Centrum Silver® (Wyeth-Whitehall laboratory).
At the middle of the radiation treatments patients were switched from placebo to MVi and vice versa.
Patients answered to the EORTC QLQ C-30 quality of life (QOL) and Chalder Fatigue Questionnaires at the beginning, the time of switching and at the end of Rxt.
We found that both groups experienced significant decreases in general and physical fatigue at the end of the course of placebo compared to the assessment prior to this treatment.
We also observed significant improvements in functional and symptoms in the patients on placebo.
When we compared different groups of patients we also observed significantly lower rates of physical and general fatigue in the patients who had just finished a course of placebo as compared to patients finishing course of MVi.
We conclude that MVi do not improve radiation related fatigue, and may in fact have a deleterious effect on fatigue and decrease QOL in patients with BC undergoing Rxt.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Multivitamins (MVi) are broadly used by cancer patients to improve overall health and energy.
Fatigue is a common symptom in cancer patients including those receiving radiation therapy.
We conducted a double blind randomized cross-over trial of MVi versus placebo in patients with breast cancer (BC) undergoing radiation therapy (Rxt) to evaluate if MVi would affect fatigue and quality of life.
We randomized forty patients at the beginning of Rxt treatment to either placebo or Centrum Silver® (Wyeth-Whitehall laboratory).
At the middle of the radiation treatments patients were switched from placebo to MVi and vice versa.
Patients answered to the EORTC QLQ C-30 quality of life (QOL) and Chalder Fatigue Questionnaires at the beginning, the time of switching and at the end of Rxt.
When we analyzed the same group of patients throughout the treatment periods, we found that both groups experienced significant decreases in general (p = 0.009; p = 0.001) and physical fatigue scores (p = 0.031; p = 0.029) at the end of the course of placebo compared to the assessment prior to this treatment.
We also observed significant improvements in functional (p = 0.026) and symptoms (p = 0.016) score scales of the QOL questionnaire in the patients on placebo.
No significant changes were elicited with the use of MVi.
When we compared different groups of patients we also observed significantly lower rates of physical and general fatigue in the patients who had just finished a course of placebo as compared to patients finishing course of MVi (0 vs 25% p = 0.035 for both types of fatigue).
We conclude that MVi do not improve radiation related fatigue, and may in fact have a deleterious effect on fatigue and decrease QOL in patients with BC undergoing Rxt.
Further studies are needed to confirm our findings.
Study Type
Interventional
Enrollment
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
(sp)
-
Santo André, (sp), Brazil
- Instituto de Radioterapia do ABC - Av. Portugal, 592 -
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- >18 years old
- breast cancer who were to receive radiation therapy to the breast after a conservative surgery or after mastectomy
Exclusion Criteria:
- previous history of radiation therapy,
- chronic anemia,
- depression
- serious psychiatric disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
fatigue
|
Secondary Outcome Measures
Outcome Measure |
---|
quality of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Auro Del Giglio, MD, FM-ABC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion
August 1, 2006
Study Registration Dates
First Submitted
October 2, 2006
First Submitted That Met QC Criteria
October 2, 2006
First Posted (Estimate)
October 3, 2006
Study Record Updates
Last Update Posted (Estimate)
October 3, 2006
Last Update Submitted That Met QC Criteria
October 2, 2006
Last Verified
October 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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