NCT06905561 Topical Diclofenac for Prevention of Radiation-induced Dermatitis
| NCT ID | NCT06905561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second Affiliated Hospital of Hainan Medical University |
| Condition | Head and Neck Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 156 participants in total. It began in 2025-02-13 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06905561 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Head and Neck Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06905561 currently recruiting?
Yes, NCT06905561 is actively recruiting participants. Contact the research team at wellyy2005@hainmc.edu.cn for enrollment information.
Where is the NCT06905561 trial being conducted?
This trial is being conducted at Haikou, China.
Who is sponsoring the NCT06905561 clinical trial?
NCT06905561 is sponsored by The Second Affiliated Hospital of Hainan Medical University. The trial plans to enroll 156 participants.