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Clinical study of radioprotective effect of triethanolamine emulsion on vaginitis: an open-label, multi-center, randomized trial

Clinical study of radioprotective effect of triethanolamine emulsion on vaginitis: an open-label, multi-center, randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125917
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Radiation vaginitis

Interventions

Observation Group:In addition to the routine care for radiotherapy of cervical cancer, triethanolamine cream (Biafin) is also used.
Control group:Conventional flushing

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old; 2. Those diagnosed with cervical cancer by histological pathology and receiving radiotherapy with a total radiation dose of >=70Gy; 3. ECOG score of 0-2 (Annex 3); 4. Normal mental state and clear consciousness; 5. Be able to cooperate with the visitor; 6. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: Any patient who meets any of the following criteria cannot be enrolled: 1. Those with severe immune deficiency (such as those who have recently received bone marrow transplantation, with long-term high-dose glucocorticoids > 20 mg/ day for more than 2 weeks); 2. Congenital vaginal malformations; 3. Patients who are pregnant, breastfeeding, or have plans and the possibility of becoming pregnant; 4. Other conditions that the researcher deems unsuitable for enrollment (such as: previous allergy history to triethanolamine cream, etc.).

Design outcomes

Primary

MeasureTime frame
The incidence and severity of radiation vaginitis;

Secondary

MeasureTime frame
Vaginal mucosal healing rate;EORTC Quality of life Questionnaire (QLQ-C30+QLQ-CX24);Visual Analogue Scale;Effective vaginal length;Bacterial flora detection;

Countries

China

Contacts

Public ContactQin Xu

Fujian Cancer Hospital

1379423879@qq.com+86 139 5041 9396

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026