Topical Steroids & Bacterial Decolonization for Radiation Dermatitis

Radiation Dermatitis Clinical Trial

Official title:

Topical Corticosteroid and Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05505214
• Other study ID #: 2022-14221
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: December 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Drug:
• Bacterial decolonization
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.
• Mometasone furoate 0.1% cream
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
• Bacterial decolonization and Mometasone furoate 0.1% cream
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

Locations

Country	Name	City	State
United States	Montefiore Medical Center-Albert Einstein College of Medicine	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in the cutaneous microbiome and transcriptome	Assessed through laboratory analysis of changes in microbial skin cultures and tape-strip gene expression analysis on skin samples before and after RT treatment	through study completion, an average of 2 years
Primary	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
Primary	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
Primary	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	Quality of life Score Change	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)	At study screening/enrollment, before RT treatment has started
Secondary	Quality of life Score Change	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)	At last RT treatment session, an average of 5 weeks after treatment initiation
Secondary	Quality of life Score Change	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)	Two weeks after RT treatment completed