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A prospective, randomized and controlled clinical study of biomimetic mucosa-ipratropium in preventing acute radiation-induced skin injury in breast cancer patients

A prospective, randomized and controlled clinical study of biomimetic mucosa-ipratropium in preventing acute radiation-induced skin injury in breast cancer patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059646
Enrollment
Unknown
Registered
2022-05-05
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Breast cancer

Interventions

Experimental group:biomimetic mucosa-ipratropium
Control group:Medical radioprotective agent (aokepen)

Sponsors

Binzhou Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis was breast carcinoma in situ and invasive breast cancer; 2. The preoperative clinical stage is Tis? 4N1? 3M0 (Ia IIIc) stage, breast cancer patients who received breast conserving surgery+postoperative radiotherapy or modified radical surgery+postoperative chest wall and regional lymph node radiotherapy; 4. The scar of the surgical incision was completely healed; 5. KPS score = 80; 6. No other malignant tumor and serious medical disease (especially radiation field skin disease and systemic lupus erythematosus); 7. Sign the written informed consent; 8. Age 18-60 years; 9. The patient has no serious endocrine and metabolic diseases; 10. Subjects can read, understand, follow the research procedures and independently complete the work required by the study.

Exclusion criteria

Exclusion criteria: 1. Subjects have mental illness and severe cognitive impairment; 2. Researchers believe that giving research treatment may confuse research results or lead to uncertainty risks; 3. Patients who refuse to follow up; 4. Patients who are allergic to related drugs; 5. Patients with skin-related diseases such as local dermatitis and breakage.

Design outcomes

Primary

MeasureTime frame
Degree of skin damage;

Secondary

MeasureTime frame
Quality of life scale;

Countries

China

Contacts

Public ContactLiu Changmin

Binzhou Medical University Hospital

byfylcm@126.com+86 543 3258761

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026