Using Diclofenac Gel to Prevent Skin Damage from Radiation Therapy

Topical Diclofenac for Prevention of Radiation-induced Dermatitis: A Single-center, Randomized Controlled Trial

This study is testing if Diclofenac gel can help prevent painful skin damage in patients getting radiation therapy for head and neck tumors or breast cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Hainan Medical University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Haikou, Hainan)
• Trial ID: NCT06905561 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Diclofenac sodium gel in preventing radiation-induced dermatitis (RID) in patients undergoing radiation therapy for head and neck tumors or breast cancer. RID is a common and painful side effect of radiation therapy that can negatively impact treatment outcomes and patient quality of life. The study aims to assess how well this topical treatment can reduce inflammation and oxidative stress associated with radiation exposure. Participants will be monitored for skin reactions and overall treatment tolerance during their radiation therapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with epithelial carcinoma of the head and neck or breast cancer who are scheduled for radiation therapy.

Not a fit: Patients with pre-existing severe skin conditions or those who have received blood transfusions within the last 14 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of painful skin reactions in patients receiving radiation therapy.

How similar studies have performed: While there have been various treatments for radiation-induced dermatitis, the specific use of Diclofenac sodium gel as a preventive measure is relatively novel and has not been extensively tested in this context.

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.

Where this trial is running

Haikou, Hainan

• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (RECRUITING)

Study contacts

• Study coordinator: yuecan zeng

Conditions: Head and Neck Tumor, Breast Cancer, Topical Diclofenac, Radiation-induced dermatitis, Prevention, Head and Neck tumor, Brest Cancer