Topical Diclofenac for Prevention of Radiation-induced Dermatitis

NCT06905561 | Recruiting

• 1 other identifier: 2025-K01-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Tumor; Breast Cancer

Keywords

Topical Diclofenac; Radiation-induced dermatitis; Prevention; Head and Neck tumor; Brest Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of development of grade ≥ 2 RID

  If the patient developed grade ≥ 2 RID or not, RTOG standards were used for evaluation

  From the first day of radiotherapy until 2 weeks after the end of radiotherapy

Secondary Outcomes (8)

• Evaluation of Time to develop grade ≥2 RID

  From the first day of radiotherapy until 2 weeks after the end of radiotherapy

• Evaluation of Pain Intensity

  From the first day of radiotherapy until 2 weeks after the end of radiotherapy

• Evaluation of Incidence of Treatment-Emergent Adverse Events

  From the first day of radiotherapy through treatment completion(up to 7 weeks or 5 weeks)

• Evaluation of Quality of life

  From the first day of radiotherapy until 2 weeks after the end of radiotherapy

• Incidence of radiotherapy interruption

  From the first day of radiotherapy through treatment completion (up to 7 weeks or 5 weeks)

Study Arms (2)

Treatment group（diclofenac sodium gel ）

EXPERIMENTAL

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.

Drug: Diclofenac Sodium Gel

control group（Placebo Comparator）

PLACEBO COMPARATOR

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.

Other: Placebo gel

Interventions

Diclofenac Sodium Gel DRUG

Diclofenac Sodium Gel were 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.

Treatment group（diclofenac sodium gel ）

Placebo gel OTHER

The placebo does not contain the active ingredients of Jalosome, only the co-formulants.

control group（Placebo Comparator）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female which are 18 years of age or older
• Performance status \< 2
• 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
• The RTOG radiation dermatitis rating should be equal to 0 and the skin nutrition should be good
• 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.
• 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.

You may not qualify if:

• Pregnant or lactating women
• A known history of intolerance or allergy to any component of the investigational product;
• 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);
• The acute phase is accompanied by inflammatory skin diseases, such as atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea.
• Systemic diseases known to delay the skin healing process, such as diabetes or severe kidney failure;
• Skin rupture caused by malignant tumors.

Sponsors & Collaborators

• The Second Affiliated Hospital of Hainan Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570311, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Central Study Contacts

yuecan zeng

CONTACT

19946610752; wellyy2005@hainmc.edu.cn

junnv xu

CONTACT

18208946196; xujunnv@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: April 1, 2025
• Study Start: February 13, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-02

Locations

CN (1)