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An explorational clinical study of selenium on the influence of gut microbiota in patients with pelvic tumor radiotherapy

An explorational clinical study of selenium on the influence of gut microbiota in patients with pelvic tumor radiotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101415
Enrollment
Unknown
Registered
2025-04-24
Start date
2024-06-11
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic tumor

Interventions

selenium supplementation group:Nano-selenium capsules were supplemented 10 days before radiotherapy and during radiotherapy.
Control group:No intervention

Sponsors

First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pelvic tumor confirmed by pathology; Need pelvic radiotherapy. 2. The score of ECOG physical status is 0-2. 3. No antibiotics or suppressants were used for 4 weeks before taking the capsule. 4. Good organ function. 5. Take part in this experiment voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Chemotherapy with fluorouracil during radiotherapy. 2. Have a history of severe hypersensitivity to selenium or products containing selenium components. 3. At the same time, there is a history of malignant tumors in other parts. 4. Other contraindications to radiotherapy and chemotherapy. 5. There is an oral capsule disorder. 6. Known history of primary immunodeficiency. 7. Other contraindications to radiotherapy or cases that cannot enter the study after evaluation by researchers.

Design outcomes

Primary

MeasureTime frame
intestinal flora;

Secondary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactYong Chen

First Affiliated Hospital of Sun Yat-sen University

chenyong@mail.sysu.edu.cn+86 138 2626 6676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026