Evaluating benefits of a polyherbal oral formulation PRA- 5 in patients with head and neck cancer undergoing chemoradiotherapy: Results of a pilot study

Abstract

Background: Radiotherapy/chemoradiotherapy (RT/CRT) causes widespread cellular damage leading to undesirable side-effects in patients with cancer. With other comorbidities, these patients are highly susceptible to infections. This pilot study assessed the benefits of an innovative oral polyherbal formulation (PRA-5) in patients with head and neck cancer (HNC) undergoing RT/CRT. Materials and methods: In this randomized, controlled, proof-of-concept study, 21 patients with HNC undergoing RT/CRT were randomized 1:1 to receive thrice daily tablets of PRA-5 (n=10) or placebo (n=11) up to 52 days. Patients were monitored weekly for acute toxicities and their various clinical, biochemical, and hematological parameters were evaluated at prespecified timepoints. Data were analyzed using ‘t’ test; a P-value of < 0.05 was considered as significant. Results: Overall, the baseline characteristics were well-balanced between the treatment groups. PRA-5 group showed 3% increase in malonaldehyde post RT/CRT compared with a 24% increase in the placebo group. Total antioxidant status, white blood cells, and platelet count decreased in patients receiving placebo whereas these parameters increased in patients receiving PRA-5. There was no significant difference in other biological and hematological parameters between the two groups. Skin reactions and oral mucositis of various grades were noted in both groups. PRA-5 showed beneficial effects in reducing oral mucositis post-RT/CRT. Conclusions: PRA-5 was well-tolerated in patients with HNC receiving RT/CRT. Compared with placebo, PRA-5 supplementation showed considerable protection from radiation-related cellular damage. The pilot study showed that PRA-5 could be used as a safe and effective supplement to reduce the RT/CRT related side-effects in patients with HNC.