Ganoderma spore powder for depressive symptoms after thyroid cancer surgery
Targeting the Gut-Brain Axis With Ganoderma Lucidum Spores Ameliorates Depression in Thyroid Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial
This project will test whether a purified Ganoderma lucidum spore powder can reduce depressive symptoms in women who have had papillary thyroid cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07524777 on ClinicalTrials.gov |
What this trial studies
This is a 3-month, randomized, double-blind, placebo-controlled trial enrolling 300 postoperative female patients with papillary thyroid carcinoma and mild-to-moderate depressive symptoms (HAMD-24 ≥ 8). Participants are randomized 2:1 to receive sporoderm-removed Ganoderma lucidum spore powder (RGLS) 4 g/day or matched placebo. The trial will monitor depressive symptom changes and collect stool and metabolic samples to explore gut microbiota and metabolite changes that might link the gut and brain. Key eligibility limits include female Han Chinese outpatients aged 18–80, no prior psychiatric disorders, and no recent antibiotics or microbiome-affecting treatments.
Who should consider this trial
Good fit: Ideal candidates are Han Chinese women aged 18–80 who are outpatients at Zhejiang Cancer Hospital, have had surgery for papillary thyroid carcinoma, and have depressive symptoms (HAMD-24 ≥ 8) without prior psychiatric disorders.
Not a fit: Patients with other gastrointestinal disease or prior GI surgery, recent antibiotics or microbiome therapies, concurrent cancers needing active systemic therapy, current antidepressant use, severe psychiatric or organic brain disease, or those unable to attend Zhejiang Cancer Hospital are unlikely to benefit from or be eligible for this intervention.
Why it matters
Potential benefit: If successful, the supplement could offer a low-risk, oral option to reduce depressive symptoms and favorably modify gut microbiota in postoperative thyroid cancer patients.
How similar studies have performed: Some preclinical work and small clinical reports suggest Ganoderma extracts can affect gut microbiota and mood, but large randomized controlled trials in postoperative cancer patients are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Outpatients at Zhejiang Cancer Hospital with histologically confirmed papillary thyroid carcinoma (post-surgery) and depressive symptoms (HAMD-24 score ≥ 8, confirmed by a clinical psychologist). * Han Chinese ethnicity. * No history of depression or other psychiatric disorders. * Age 18-80 years. * Female. Exclusion Criteria: * Suffering from other gastrointestinal system diseases. * History of gastrointestinal surgery prior to intervention. * Including those with other concurrent malignancies requiring chemotherapy, radiotherapy, biological therapy, or traditional Chinese medicine treatment. * Received antibiotic treatment or microecological modulators within 3 months prior to intervention. * Acute intestinal obstruction. * Patients who are currently taking antidepressant medication, or those whom the investigators judge require immediate initiation of antidepressant medication treatment. * Organic brain diseases, brain trauma. * History of psychiatric disorders, use of psychoactive substances (e.g., drugs). * Severe liver or kidney dysfunction. * Pregnancy or lactation.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Zhiqiang Ling
- Email: lingzq@zjcc.org.cn
- Phone: +86-571-88122423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.