Clinical trial · Interventional
Topical Doxepin for Radiation-induced Dermatitis
Topical Doxepin for Prevention and Management of Radiation-induced Dermatitis
- 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 dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities such as radiation dermatitis encountered in clinical practice are typically managed with a variety of topical agents such as water-based moisturizing creams or lotions, topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for the prevention and treatment of these toxicity can be used to protect skin against radiation damage.Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin for the prevention and management of radiation-induced dermatitis during postoperative radiotherapy for breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxepin cream 5% | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- doxepin cream
- description
- Patients use doxepin cream 5% twice daily for two weeks
- interventionNames
- Drug: Doxepin cream 5%
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients use cream without doxepin ingredient twice daily for two weeks
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria
- timeFrame
- At the beginning of 5th week of radiotherapy to two weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female with a diagnosis of, breast adenocarcinoma and be referred for post-operative radiotherapy with or without concurrent chemotherapy and with or without mastectomy * Participants must not be pregnant. * Participants treated with a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week Exclusion Criteria: * Patients who are not eligible * The presence of skin diseases in the radiation area * Patients have constipation, xerostomia, blurred vision, urinary retention * Hypersensitivity to doxepin
References
Publications (0)
Data not yet available