Colodny, L., Lynch, K., Farber, C., Papish, S., Phillips, K., Sanchez, M., . . . Block, J. (2000). Results of a study to evaluate the use of Propax to reduce adverse effects of chemotherapy. Journal of the American Nutraceutical Association, 3, 17–25.

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.