Clinical trial · Interventional
Topical Diclofenac for Prevention of Radiation-induced Dermatitis
Topical Diclofenac for Prevention of Radiation-induced Dermatitis: A Single-center, Randomized Controlled Trial
NCT06905561CI-TRIAL-00107220recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. The Diclofenac is a COX-2 inhibitor and Nonsteroidal anti-inflammatory drugs whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Diclofenac sodium gel as a prophylactic method against the development of RID.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Tumor | Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diclofenac Sodium Gel | Drug | — | UNRESOLVED |
| Placebo gel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group（diclofenac sodium gel ）
- description
- In addition to routine skin care, diclofenac sodium gel was applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.Conventional health care:Minimize skin irritation, friction and excessive sun exposure in the irradiated area (level III to IV evidence), avoid wearing high-neck and tight clothing, and recommend low-neck tops. Subjects wash irradiated skin with water or wet towel, and wipe skin with dry towel to keep irradiated skin clean and dry.
- interventionNames
- Drug: Diclofenac Sodium Gel
- type
- PLACEBO_COMPARATOR
- label
- control group（Placebo Comparator）
- description
- In addition to routine skin care, Placebo gel was applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.Conventional health care:Minimize skin irritation, friction and excessive sun exposure in the irradiated area (level III to IV evidence), avoid wearing high-neck and tight clothing, and recommend low-neck tops. Subjects wash irradiated skin with water or wet towel, and wipe skin with dry towel to keep irradiated skin clean and dry.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and female which are 18 years of age or older 2. Performance status \< 2 3. Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy 4. The RTOG radiation dermatitis rating should be equal to 0 and the skin nutrition should be good 5. The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB ≥ 100g/L, b. WBC ≥3×10\^9/L c. ANC≥1.5×10\^9/L, d. PLT ≥100×10\^9/L; (2) Biochemical examination must meet the following standards: a. BIL\<1.5 times the upper limit of normal value (ULN), b. ALT and AST\<2.5ULN, GPT ≤1.5×ULN; c. Serum Cr≤1 ULN, endogenous creatinine clearance rate\>60ml/min (Cockcroft Gault formula);(3).Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;(4).The myocardial enzyme spectra were in the normal range. 6. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures. Exclusion Criteria: 1. Pregnant or lactating women 2. A known history of intolerance or allergy to any component of the investigational product; 3. severe cardiopulmonary disease (such as unstable angina attacks, grade II cardiac insufficiency, acute myocardial infarction, acute episodes of chronic obstructive pulmonary disease, pulmonary heart disease); 4. The acute phase is accompanied by inflammatory skin diseases, such as atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea. 5. Systemic diseases known to delay the skin healing process, such as diabetes or severe kidney failure; 6. Skin rupture caused by malignant tumors.
References
Publications (0)
Data not yet available
No reference posted for this study.