Zhao, H., Zhang, Q., Zhao, L., Huang, X., Wang, J., & Kang, X. (2012). Spore powder of Ganoderma lucidum improves cancer-related fatigue in breast cancer patients undergoing endocrine therapy: a pilot clinical trial. Evidence-Based Complementary and Alternative Medicine, 809614.

To evaluate whether spore powder of Ganoderma lucidum (G. lucidum) has beneficial effects on fatigue and overall quality of life in patients with breast cancer undergoing endocrine therapy.

Patients in the experimental group received spore powder of G. lucidum 1,000 mg three times a day for four weeks (from Beijing Great Wall Pharmaceutical Factory, batch # B20050008). This is a traditional Chinese medicine that contains polysaccharides, alkaloids, enzymes, and proteins. The control group received placebo for four weeks. Outcomes were evaluated at baseline and the end of four weeks. 

• The total sample was comprised of 48 women, with 25 patients in the experiemental group and 23 in the control group.  
• Median age was 51.3 years (standard deviation [SD] = 9.8) in the experiemental group and 53.2 years (SD = 8.7) in the control group (p > 0.1).
• Patients were stage I to IIIA. 
• Multimodal treatment included surgery, radiation and/or chemotherapy, and endocrine therapy for all patients. 
• Duration of endocrine therapy varied from more than six months to up to five years. 
• No statistically significant differences existed between the groups.
• Patients received endocrine therapy for breast cancer.
   

The study was conducted at the Third Affiliated Hospital of Harbin Medical University in Harbin, China, from June 2009 to September 2010.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for patients undergoing endocrine therapy.
   

The study was a randomized, placebo-controlled trial.

• Functional Assessment of Cancer Therapy–Fatigue (FACT-F)
• Hospital Anxiety and Depression Scale (HADS)
• European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30)
• Biological Markers of Fatigue:  tumor necrosis factor (TNF) and interleukin-6 (IL-6)
• Safety and toxicity tests, such as a renal function test, liver function test, and the Common Toxicity Criteria version 2.0 scale
• Fatigue was measured with a single-item numeric rating scale with possible values from 0 (a great deal of fatigue) to 10 (no fatigue).
• Energy was measured with a single item, “How much energy have you had during the past 4 weeks?,” with possible values from 0 (no energy at all) to 10 (a great deal of energy).
   

No serious adverse effects occurred. No significant changes occurred in the renal and liver function tests. Fatigue scores were improved in the experimental group at four weeks (p < 0.01), but no significant improvement occurred in the control group. At four weeks, anxiety and depression scores had improved significantly from baseline in the experimental group. No significant improvement occurred over time in the control group.

The pilot suggested that spore powder G. lucidum may have beneficial effects on cancer-related fatigue and quality of life in patients with breast cancer undergoing endocrine therapy with no significant safety concerns.

• The study had a small sample size, with less than 100 patients.
• Nonspecific aspects of the intervention (social support) may influence the study. 
• Patients were healthy (e.g., no other comorbid conditions).
• No blinding was performed.
   

Additional research should be conducted in a larger randomized, controlled trial.