Multivitamins do Not Improve Radiation Therapy Related Fatigue
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
multivitamins
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast, cancer, fatigue, multivitamins
Eligibility Criteria
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
Sites / Locations
- Instituto de Radioterapia do ABC - Av. Portugal, 592 -
Outcomes
Primary Outcome Measures
fatigue
Secondary Outcome Measures
quality of life
Full Information
NCT ID
NCT00383409
First Posted
October 2, 2006
Last Updated
October 2, 2006
Sponsor
Faculdade de Medicina do ABC
1. Study Identification
Unique Protocol Identification Number
NCT00383409
Brief Title
Multivitamins do Not Improve Radiation Therapy Related Fatigue
Official Title
Multivitamins do Not Improve Radiation Therapy Related Fatigue: Results of a Double-Blind Randomized Cross-Over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Faculdade de Medicina do ABC
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast, cancer, fatigue, multivitamins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
multivitamins
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
fatigue
Secondary Outcome Measure Information:
Title
quality of life
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auro Del Giglio, MD
Organizational Affiliation
FM-ABC
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Radioterapia do ABC - Av. Portugal, 592 -
City
Santo André
State/Province
(sp)
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Multivitamins do Not Improve Radiation Therapy Related Fatigue
We'll reach out to this number within 24 hrs