To assess the effectiveness of the dietary supplement Propax® with NTFactor®® in reducing chemotherapy-induced fatigue, nausea and vomiting, and other selected clinical side effects associated with chemotherapy.
Using a crossover placebo-controlled, randomized, double-blinded design, 36 patients with cancer were enrolled in the 12-week pilot study. Simultaneously, an open-label trial of Propax in 22 other patients with cancer was similarly implemented. Recommended daily dose of the study product was 12 tablets and 3 soft-gel capsules daily.
The consumption of the recommended daily dosage of the dietary supplement Propax‘ with NTFactor® resulted in an improvement or no change or worsening in chemotherapy-related side effects of fatigue, nausea, impaired taste, diarrhea, general tiredness, constipation, and insomnia. Other chemotherapy induced
toxicities (mouth sores, skin changes, and decreased appetite) were not similarly benefited and progressively became more severe throughout the progression of the study. These results were assessed by standard Quality of Life (QOL) questionnaires completed by patients and nurses in the offices of oncologists participating in the study. No reported adverse drug events considered to be severe were reported in the study, and when present most were related to mild non-specific gastrointestinal discomfort.
Fatigue is one of the most common complaints in cancer patients. The results of this pilot study, both open-label and double-blinded placebo-crossover in design, indicate that patient perception of benefit with Propax‘ supplementation to chemotherapy is significant in reducing fatigue and other chemotherapy-induced toxicities. As chemotherapy toxicity is expected to worsen or progress with continued therapy, such improvement or lack of worsening of side effects is an important outcome. The results from the blinded study were very similar to the results from the unblinded study both with regard to patient documentation of their symptoms, and nurses’ assessments.
Propax‘ with NTFactor® supplementation to standard chemotherapy regimens had beneficial
impact on several quality
of life parameters with a high degree of patient acceptance of the supplementation regimen that was also confirmed by nurse observations.