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Innovative Role of a Novel Non-Pharmacological Analgesic Device in the Treatment of Radiation-Induced Skin Injury Pain: A Prospective, Double-Blind, Randomized Controlled Study Comparing Combined Therapy with Biafine® Medical Radiation-Protective Spray and Non-Steroidal Anti-Inflammatory Drugs versus Standard Therapy Alone

Prospective, Double-Blind, Randomized Controlled Study: Therapeutic Effect and Innovative Application of Novel Non-Pharmacological Analgesic Devices in the Treatment of Radiation-Induced Skin Injury Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123027
Enrollment
Unknown
Registered
2026-04-21
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Radiation-induced skin injury

Interventions

treatment group:New non-pharmacological pain relief devices (sterile water-soaked patches, changed every 2 days) + Sterile water spray (placebo, administered 3 times daily) + Oral placebo capsules (in
control group:Yabifeng Medical Radiation Protection Spray (3 times daily) + Oral Ibuprofen Sustained-release Capsules (0.3g per dose, twice daily) + Placebo Dressing (changed every 2 days)

Sponsors

The Sixth Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with RTOG grade II-III radiation-induced skin injury; 2. Patients with NRS pain score >=4 due to radiation-induced skin injury; 3. Patients with recurrent and non-healing radiation-induced skin injury; 4. Patients without long-term use of analgesics, history of alcoholism, or drug abuse; 5. Patients with normal liver, kidney, and coagulation function; 6. Patients who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with radiation-induced pain in tissues or organs other than the skin (e.g., mucosa, throat, esophagus, digestive tract); 2. Patients with chronic cancer pain; 3. Patients with severe cardiovascular, cerebrovascular, pulmonary, liver, kidney, respiratory, hematological, or neurological diseases; 4. Pregnant or breastfeeding women; 5. Patients with cognitive impairment who cannot cooperate with the study procedures.

Design outcomes

Primary

MeasureTime frame
Sum of Pain Intensity Difference over 168 hours;—

Secondary

MeasureTime frame
The duration during which the NRS score decreased by = 2 points compared to the baseline;The incidence rate of adverse reactions to analgesics;The onset time of treatment for radioactive skin damage: The time when the RTOG grade decreased by 1 level compared to the baseline;Effective rate of radioactive skin injury treatment: (Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100%;—

Countries

China

Contacts

Public ContactRunping Yang

The Sixth Medical Center, Chinese PLA General Hospital

yrp809@163.com+86 186 0031 0938

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026