NCT07524777

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable depression

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

April 1, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

April 11, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

April 1, 2026

Last Update Submit

May 7, 2026

Conditions

DepressionThyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention

    3 months

Secondary Outcomes (3)

  • 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

  • Change in serum metabolites from baseline to 3 months of RGLS intervention.

    3 months

Other Outcomes (2)

  • Incidence of adverse events in both groups, including patient-reported symptoms and laboratory parameters.

    3 months

  • Improvement rate of thyroid function in both groups, assessed by thyroid function parameters.

    3 months

Study Arms (2)

Sporoderm-removed Ganoderma lucidum spore powder (RGLS)

EXPERIMENTAL
Dietary Supplement: Sporoderm-removed Ganoderma lucidum spore powder (RGLS)

placebo group

PLACEBO COMPARATOR
Other: Placebo

Interventions

Sporoderm-removed Ganoderma lucidum spore powder (RGLS)DIETARY_SUPPLEMENT

From the first day after enrollment, subjects take RGLS orally at 4g/day for 3 months.

Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
PlaceboOTHER

From the first day after enrollment, subjects take placebo orally at 4g/day for 3 months.

placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

DepressionThyroid Neoplasms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Zhiqiang Ling

CONTACT

+86-571-88122423lingzq@zjcc.org.cn

Jinbiao Shang

CONTACT

shangjb@zjcc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof., M.D., PhD,

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 13, 2026

Study Start

April 11, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 12, 2026

Record last verified: 2026-03

Locations

CN(1)