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Multivitamins do Not Improve Radiation Therapy Related Fatigue: Results of a Double-Blind Randomized Cross-Over Trial

Phase 2
18 Years
75 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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 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 SilverĀ® (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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Auro Del Giglio, MD

Investigator Role:

Study Director

Investigator Affiliation:



Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

March 2006

Completion Date:

August 2006

Related Keywords:

  • Breast Cancer
  • breast
  • cancer
  • fatigue
  • multivitamins
  • Breast Neoplasms
  • Fatigue