Multivitamins do Not Improve Radiation Therapy Related Fatigue

This study has been completed.
Sponsor:
Information provided by:
Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT00383409
First received: October 2, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: multivitamins
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multivitamins do Not Improve Radiation Therapy Related Fatigue: Results of a Double-Blind Randomized Cross-Over Trial

Resource links provided by NLM:


Further study details as provided by Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • fatigue

Secondary Outcome Measures:
  • quality of life

Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383409

Locations
Brazil
Instituto de Radioterapia do ABC – Av. Portugal, 592 –
Santo André, (sp), Brazil
Sponsors and Collaborators
Faculdade de Medicina do ABC
Investigators
Study Director: Auro Del Giglio, MD FM-ABC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00383409     History of Changes
Other Study ID Numbers: 199/2005
Study First Received: October 2, 2006
Last Updated: October 2, 2006
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Medicina do ABC:
breast
cancer
fatigue
multivitamins

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014