Multivitamins do Not Improve Radiation Therapy Related Fatigue
Condition: Breast Cancer
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): multivitamins; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: breast; cancer; fatigue; multivitamins