Multivitamin Supplements

In both studies, the dose of Propax was given to patients three times daily in a packet that contained four tablets and one softgel capsule. Supplements were administered with food to limit potential gastrointestinal upset. In the open-label study, patients received the Propax nutritional supplementation five to seven days prior to chemotherapy treatments and continued throughout the next 12 weeks of the chemotherapy regimen. After six weeks of chemotherapy, patients crossed over to the other product (placebo to Propax or Propax to placebo). Outcomes were evaluated at baseline, week 6 (mid-point), and week 12 (end of the intervention).

• The sample was comprised of 16 patients who completed the unblinded study and 22 patients who completed crossover randomized, controlled trials.
• Cancer diagnoses varied, including advanced unresectable non-small cell, small cell lung, colon, rectal, pancreatic, sarcoma, breast, or ovarian cancers.
• Patients were excluded if they were younger than 21 years, women of childbearing age, mentally incompetent, renally impaired, had serum bilirubin of 2.0 mg/dL or higher, had weight loss greater than 15% within the last four months, spent more than 50% of waking time in bed, or were currently consuming vitamin or nutritional supplements.

Outpatient chemotherapy centers in California, Florida, Maine, Massachusetts, New Jersey, and New York

Patients were undergoing the active treatment phase of care.

This was a crossover, placebo-controlled, randomized, controlled, trial and a pilot open-label study.

The article did not discuss which measurement instruments were used.

In the open-label trial, patients reported significant improvements in fatigue (>0.5 change in score). Patients who began with Propax in the crossover randomized, controlled trial reported improvement in fatigue during the 12-week study period. Patients who began with the placebo experienced improved quality of life; however, fatigue was not specifically mentioned.

• The study had a small sample size.
• The duration of the crossover study was short; therefore, the rapid crossover design may not have permitted adequate separation from Propax effects and placebo effects.

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).

• 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.

Patients were undergoing the active treatment phase of care.

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

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

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).