Topical Steroids & Bacterial Decolonization for Radiation Dermatitis

Phase 2

Withdrawn

• Conditions: Radiation Dermatitis
• Interventions: Drug: Bacterial decolonization; Drug: Mometasone furoate 0.1% cream; Drug: Bacterial decolonization and Mometasone furoate 0.1% cream

• Registration Number: NCT05505214
• Lead Sponsor: Montefiore Medical Center

Brief Summary

The purpose of this study is to determine whether bacterial decolonization of the nares and skin, topical steroid therapy, or a combination of the two regimens prior to treatment with radiotherapy (RT) for breast and head and neck cancer patients can prevent grade 2 or higher grade radiation dermatitis (RD) graded via the Common Terminology Criteria for Adverse Events (CTCAE) scale and improve quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Study Start: 2023-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-16
• Last Update Posted: 2023-12-22
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age greater than or equal to 18
• Diagnosis of a breast or head and neck cancer with plans for fractionated RT (greater than or equal to 15 fractions in 40 Gy (Gray)) with curative intent, including post-operative patients deemed eligible for RT by their surgeons and radiation oncologists

Exclusion Criteria

• Prior RT to the region of interest
• Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds; known allergy to intervention therapies)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacterial decolonization	Bacterial decolonization	Validated decolonization regimen
Topical corticosteroid	Mometasone furoate 0.1% cream	Mometasone furoate 0.1% cream
Combination	Bacterial decolonization and Mometasone furoate 0.1% cream	Validated decolonization regimen and mometasone furoate 0.1% cream

Primary Outcome Measures

Name	Time	Method
Incidence of grade >2 RD	Two weeks after RT treatment completed	Assessed via the CTCAE scale before and after RT treatment via clinical photographs graded by a blinded dermatologist (minimum grade 0, maximum grade 5, higher score is worse outcome)

Secondary Outcome Measures

Name	Time	Method
Quality of life Score Change	Two weeks after RT treatment completed	Assessed by the Skindex-16 survey given to the patient before and after RT treatment (minimum score 0, maximum score 96, higher score is worse outcome)

Trial Locations

Locations (1)

Montefiore Medical Center-Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States