Efficacy and safety of Lignosus rhinocerus (Cooke) Ryvarden TM02® supplementation for immune-challenged patients with localised breast cancer in remission: a randomised controlled trial.

Purpose of study: This study aimed to evaluate the safety and effectiveness of TM02^® in improving health-related quality of life (HRQoL) and fatigue in patients with localized breast cancer who had completed surgery and chemotherapy, addressing both acute and long-term side effects.

Methods: This phase II randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of TM02^® supplementation in patients who had completed surgery and chemotherapy for localized breast cancer, using HRQoL scores. A total of 52 patients were randomized into two groups: (i) TM02^® (n = 26; 1,040 mg daily for 6 months) and (ii) placebo (n = 26). HRQoL scores were assessed using the EORTC-QLQC30 and QLQ-BR23 questionnaires at five time points. Fatigue scores were measured using the FACIT-Fatigue Scale, and the safety profile of TM02^® was also evaluated. Data were analyzed on a per-protocol basis.

Results: The Global Health Status (GHS) score showed a significant within-patient effect across five visits (p = 0.001; F = 0.276). A trend toward improved physical functioning and reduced fatigue was observed in the TM02^® group compared to the placebo group. TM02^® was safe for consumption, with no significant differences in side effects between the two groups.

Conclusions: Our study found that TM02^®, a natural supplement containing standardized compounds from Lignosus rhinocerus, is well tolerated in patients with localized breast cancer post-adjuvant chemotherapy. TM02^® supplementation showed a positive trend towards improved physical functioning and reduced fatigue scores.