Topical Steroids & Bacterial Decolonization for Radiation Dermatitis

NCT05505214 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2022-14221
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (3)

• Incidence of grade >2 RD

  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)

  At study screening/enrollment, before RT treatment has started

• Incidence of grade >2 RD

  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)

  At last RT treatment session, an average of 5 weeks after treatment initiation

• Incidence of grade >2 RD

  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)

  Two weeks after RT treatment completed

Secondary Outcomes (3)

• Quality of life Score Change

  At study screening/enrollment, before RT treatment has started

• Quality of life Score Change

  At last RT treatment session, an average of 5 weeks after treatment initiation

• Quality of life Score Change

  Two weeks after RT treatment completed

Other Outcomes (1)

• Changes in the cutaneous microbiome and transcriptome

  through study completion, an average of 2 years

Study Arms (3)

Bacterial decolonization

EXPERIMENTAL

Validated decolonization regimen

Drug: Bacterial decolonization

Topical corticosteroid

EXPERIMENTAL

Mometasone furoate 0.1% cream

Drug: Mometasone furoate 0.1% cream

Combination

EXPERIMENTAL

Validated decolonization regimen and mometasone furoate 0.1% cream

Drug: Bacterial decolonization and Mometasone furoate 0.1% cream

Interventions

Bacterial decolonization DRUG

Validated decolonization regimen consisting of intranasal 2% mupirocin ointment applied twice daily as well as chlorhexidine wash used daily to the body. This regimen is conducted by the patient for 5 consecutive days prior to the start of RT and is repeated for an additional five days every other week continuing until either the development of moist desquamation or 2 weeks after the completion of RT.

Bacterial decolonization

Mometasone furoate 0.1% cream DRUG

Mometasone furoate 0.1% cream to be applied twice a day to the irradiated area, starting on the first day of RT and continuing until either the development of moist desquamation or 2 weeks after the completion of RT

Topical corticosteroid

Bacterial decolonization and Mometasone furoate 0.1% cream DRUG

Validated decolonization regimen consisting of intranasal 2% mupirocin ointment applied twice daily as well as chlorhexidine wash used daily to the body. This regimen is conducted by the patient for 5 consecutive days prior to the start of RT and is repeated for an additional five days every other week continuing until either the development of moist desquamation or 2 weeks after the completion of RT. Also, mometasone furoate 0.1% cream will be applied twice a day to the irradiated area, starting on the first day of RT and continuing until either the development of moist desquamation or 2 weeks after the completion of RT

Combination

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center-Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yana Kost

  Montefiore Medical Center

  STUDY DIRECTOR

• Lindsay Pattison

  Montefiore Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prior to recruitment, the study statistician conducted randomization in a 1:1:1 model, which will divide patients into three arms: (a) bacterial decolonization regimen (b) topical corticosteroid use daily or (c) topical corticosteroid use daily with antibacterial decolonization regimen.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)