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Purpose of study <p>This study aimed to evaluate the safety and effectiveness of TM02<sup>®</sup> 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.</p> Methods <p>This phase II randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of TM02<sup>®</sup> 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<sup>®</sup> (<i>n</i> = 26; 1,040&#xa0;mg daily for 6 months) and (ii) placebo (<i>n</i> = 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<sup>®</sup> was also evaluated. Data were analyzed on a per-protocol basis.</p> Results <p>The Global Health Status (GHS) score showed a significant within-patient effect across five visits (<i>p</i> = 0.001; F = 0.276). A trend toward improved physical functioning and reduced fatigue was observed in the TM02<sup>®</sup> group compared to the placebo group. TM02<sup>®</sup> was safe for consumption, with no significant differences in side effects between the two groups.</p> Conclusions <p>Our study found that TM02<sup>®</sup>, a natural supplement containing standardized compounds from <i>Lignosus rhinocerus</i>, is well tolerated in patients with localized breast cancer post-adjuvant chemotherapy. TM02<sup>®</sup> supplementation showed a positive trend towards improved physical functioning and reduced fatigue scores.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月31日

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  • Jie Yi Eng,
  • Po Lin Ooi,
  • Mariam Zafirah,
  • Mahmoud Danaee,
  • Marniza Saad,
  • Muhammad Fazril Mohamad Razif,
  • Nor Aishah Taib,
  • Chee Loong Lam,
  • Zamri Chik,
  • Shin-Yee Fung

摘要

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.