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A single-center, randomized, controlled, open interventional clinical study of nano-selenium in alleviating radiation dermatitis in patients with adjuvant radiotherapy after mastectomy for breast cancer

A single-center, randomized, controlled, open interventional clinical study of nano-selenium alleviating radiation dermatitis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092412
Enrollment
Unknown
Registered
2024-11-15
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

radiodermatitis

Interventions

Selenium supplement group:The study group also took 300µg nano-selenium capsules orally once a day, starting from 14 days before radiotherapy until 90 days after oral administration.
Control group:None

Sponsors

Jieyang People’s Hospital (Jieyang Affiliated Hospital, Sun Yatsen University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Pathological examination confirmed unilateral invasive breast carcinoma, including ductal carcinoma, lobular carcinoma, tubule carcinoma, mucinous adenocarcinoma, papillary carcinoma, mixed type and metaplastic carcinoma; 2.The surgical method was breast cancer mastectomy; 3. Postoperative adjuvant radiotherapy needs to irradiate lymph nodes in the +/- region of the chest wall; 4.ECOG physical status score is 0-2 points; 5. the age has reached 18 years old, and there is no "exclusion criteria"; 6.Voluntarily participate in the experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Have a history of allergic reaction to selenium or selenium-containing drugs; 2. Patients who take selenium-rich health care products for a long time; 3.There are oral drug disorders; 4.Known history of primary immunodeficiency; 5.Pregnant or lactating women; 6.At the time of diagnosis, there are serious medical complications, dysfunction of important organs (heart, lung, liver, kidney) or neuropsychiatric diseases; 7.Previous history of cervical and thoracic radiotherapy; 8.Other contraindications to radiotherapy or cases that could not be included in the study as assessed by the investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of radiation dermatitis above grade 2;

Secondary

MeasureTime frame
Blood selenium and selenase levels;Radiation lung injury, hematological toxicity;Regulation of anti-tumor immune response in vivo;

Countries

China

Contacts

Public ContactFanjun Meng

Jieyang People’s Hospital (Jieyang Affiliated Hospital, Sun Yatsen University)

1220561512@qq.com+86 139 0275 2590

Outcome results

None listed

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