Bacterial Decolonization to Prevent Radiation Dermatitis

NCT03883828 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2018-9722
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Incidence of High Grade Radiation Dermatitis

  The number of high-grade radiation dermatitis events (grade 2-5) were assessed at the end of treatment. Instances of Grade 2-5 radiation dermatitis was assessed using photographs taken during the final radiation therapy visit. A blinded dermatologist viewed the images and assessed for toxicity grading using CTCAE Version 5.0 criteria.

  Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks

• Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey

  Change in quality of life from the beginning to the end of radiation therapy was used to assess if patients receiving decolonization experienced less impact on quality of life compared to standard of care radiation therapy treatment based on the Skindex-16 survey. The Skindex-16 is a validated 16-item self-administered survey instrument that measures the effects of skin disease on patients' quality of life. Scores were determined based on changes from baseline in the three scale subcategories: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30) where 0 = never bothered and 6 = always bothered. Net positive changes in respective subscale scoring were correlated with an improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring corresponded to a decrease in that particular Quality of life assessment.

  From the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.

Drug: Chlorhexidine gluconate solution; Drug: Mupirocin Ointment

Control

NO INTERVENTION

Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.

Interventions

Chlorhexidine gluconate solution DRUG

Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.

Treatment Arm

Mupirocin Ointment DRUG

Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated radiation therapy (≥ 15 fractions) with curative intent

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 chlorhexidine or mupirocin

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Kost Y, Deutsch A, Mieczkowska K, Nazarian R, Muskat A, Hosgood HD, Lin J, Daily JP, Ohri N, Kabarriti R, Shinoda K, McLellan BN. Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):940-945. doi: 10.1001/jamaoncol.2023.0444.

  PMID: 37140904 DERIVED

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Beth McLellan
• Organization: Montefiore Medical Center

bmclella@montefiore.org

718.862.8840

Study Officials

• Beth McLellan, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: March 21, 2019
• Study Start: June 3, 2019
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)