Effect of Maitake D-fraction in Advanced Laryngeal and Pharyngeal Cancers During Concurrent Chemoradiotherapy: A Randomized Clinical Trial

Authors: Qinglei Hu and Binli Xie

Journal: Acta Biochimica Polonica

Study Design: Randomized, placebo-controlled trial

Participants: 141 patients with advanced laryngeal or pharyngeal cancer

Trial Length: The median observation was 42.3 ± 22.5 months for the Maitake D-Fraction group and 39.6 ± 27.2 months for the placebo group

Intervention:

• Maitake D-Fraction group: Maitake capsules (containing Grifola frondosa extract) orally 3 times a day, 4 capsules each time, one hour before meals, during concurrent chemoradiotherapy (CCRT)
• Placebo group: Placebo capsules on the same schedule during CCRT

Primary Outcomes:

• Adverse events
• Quality of life (QOL), assessed by EORTC QLQ-C30 and EORTC QLQ-H&N-35 questionnaires

Secondary Outcome: Overall survival (OS)Summary: The study investigated the effects of Maitake D-fraction on CCRT-related adverse events and QOL in patients with advanced laryngeal and pharyngeal cancers. The results showed that Maitake D-fraction reduced the frequency of severe adverse events and improved QOL scores, particularly global QOL and physical function, compared to the placebo. The Maitake D-fraction group also showed a higher proportion of patients returning to baseline QOL scores and a trend toward improved OS. The study suggests that Maitake D-fraction may be a beneficial adjuvant therapy to alleviate CCRT-related side effects and enhance QOL in these patients.