Topical Steroids & Bacterial Decolonization for Radiation Dermatitis

Montefiore Medicine Academic Health System

Status and phase: Withdrawn; Phase 2

Conditions: Radiation Dermatitis

Treatments: Drug: Bacterial decolonization; Drug: Mometasone furoate 0.1% cream; Drug: Bacterial decolonization and Mometasone furoate 0.1% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05505214

2022-14221

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Bacterial decolonization

Experimental group

Description:

Validated decolonization regimen

Treatment:

Drug: Bacterial decolonization

Topical corticosteroid

Experimental group

Description:

Mometasone furoate 0.1% cream

Treatment:

Drug: Mometasone furoate 0.1% cream

Combination

Experimental group

Description:

Validated decolonization regimen and mometasone furoate 0.1% cream

Treatment:

Drug: Bacterial decolonization and Mometasone furoate 0.1% cream