Depression, Thyroid Cancer
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSporoderm-removed Ganoderma lucidum spore powder (RGLS)
From the first day after enrollment, subjects take RGLS orally at 4g/day for 3 months.
OTHERPlacebo
From the first day after enrollment, subjects take placebo orally at 4g/day for 3 months.
Sponsors
Ling Zhiqiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum metabolites from baseline to 3 months of RGLS intervention. | 3 months |
| Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 3 months of RGLS intervention. | 3 months |
| Changes in gut microbial species from baseline to 3 months of RGLS intervention. | 3 months |
Countries
China
Outcome results
None listed