de Souza Fêde, A. B., Bensi, C. G., Trufelli, D. C., de Oliveira Campos, M. P., Pecoroni, P. G., Ranzatti, R. P., . . . Del Giglio, A. (2007). Multivitamins do not improve radiation therapy-related fatigue: results of a double-blind randomized crossover trial. American Journal of Clinical Oncology, 30, 432–436.

DOI Link

Study Purpose

Patients were randomized to two groups. Group A received the placebo for the first phase of the study and then switched to receiving multivitamins for the second phase. Group B received multivitamins for the first phase of the study and then switched to receiving placebo for the second phase. The multivitamins provided for patients were Centrum Silver tablets. To keep patients and researchers blinded, Centrum Silver tablets were crushed and offered to patients within capsules identical to those containing placebo. Randomization was centralized by a pharmacist to maintain the blinding of patients and investigators. Patient outcomes were assessed at baseline (phase I), at the time of switching (phase II), and right before the start of the last radiation treatment (phase III).

Sample Characteristics

  • The sample was comprised of 40 women with breast cancer who were to receive radiation therapy to the breast after breast-conserving surgery or after mastectomy.
  • Group A included 19 patients (mean age = 57.47 years); 63.2% were living with a companion, 78.9% were White, 89.5% were not working outside the home, 84.3% had children in elementary school or younger, 26.3% were in each stage (I, II, and III), 73.6% had breast-conserving surgery, 47.4% had hypertension, and 68.5% had prior chemotherapy.
  • Group B included 16 patients (mean age = 57.56 years); 56.3% were living with a companion, 56.3% were White, 93.7% were not working outside the home, 81.2% had children in elementary school or younger, 37.5% had an unknown tumor stage, 75% had breast-conserving surgery, 25% had hypertension, and 75% had prior chemotherapy.
  • Patients were excluded if they had a previous history of radiation therapy, chronic anemia, depression, or serious psychiatric disorders.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a double-blind, randomized, crossover trial with two groups:  multivitamin and placebo.

Measurement Instruments/Methods

  • Chalder Fatigue Scale
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Results

No significant changes were elicited in fatigue outcomes by the multivitamin intervention. When groups were compared at phase I, no significant differences were found in fatigue. At phase II, group A had a significantly lower rate of general and physical fatigue than group B (p = 0.035). The Chalder Fatigue Scale scores of both general and physical fatigue reflected a trend in the same direction (p = 0.048).