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Sponsor: Ling Zhiqiang
Conditions: Depression, Thyroid Cancer
Interventions: Sporoderm-removed Ganoderma lucidum spore powder (RGLS), Placebo
Countries: China
This study aims to investigate whether Sporoderm-removed Ganoderma lucidum spore powder (RGLS) ameliorates depression in thyroid cancer patients through gut-brain axis modulation, and to elucidate the underlying microbial and metabolic mechanisms. This 3-month randomized, double-blind, placebo-controlled trial will enroll 300 postoperative papillary thyroid carcinoma patients with depressive symptoms (HAMD-24 ≥ 8). Participants will be randomly assigned(2 : 1) to receive RGLS (4 g/day) or matched placebo.
Sex: FEMALE
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Hangzhou, Zhejiang, China