Clinical trial NCT04630821: Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis
Official title: Pilot Study of Utilizing Topical Sodium Hypochlorite to Ameliorate or Reduce Radiation Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study.

This 3-week single-arm pilot study will collect information on subject treatment compliance and feedback from subjects (and nurses/subject's treating oncologist) on the acceptability of the use of the treatment. We will also collect data on Common Terminology Criteria for Adverse Events and patient reported outcomes measured using the pain and pruritus PROMIS short-form tools and patient reported outcomes, measured using the Dermatology Life Quality Index (DLQI) tool.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Been diagnosed with head and neck cancer requiring radiation therapy or skin cancer requiring radiation treatment to the neck
* Are scheduled for a radiation therapy planning session (CT simulation)
* Have a scheduled radiation therapy start date within 1 to 2 weeks from the CT simulation
* Are able to comply with the study protocol

Exclusion Criteria:

* Patients who are pregnant, which may lead to discontinuation of radiation therapy
* Patients currently on immunotherapy
* Active or past history of inflammatory lesions in the radiation field that could interfere with assessment
* Patients who are undergoing re-irradiation to the head and neck
* Patients must not have any other condition or situation beyond those listed above which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
* Patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible.
* Participation in other clinical trials that would alter the radiation dose typically utilized for definitive chemo and radiation therapy treatment of head and neck cancer.
* Use of other topical treatments on the skin in the treatment field. No other products are allowed except Aquaphor® ointment.

Primary outcomes:
measure: Compliance with compress application
timeFrame: 3 weeks
measure: Occurrence of adverse events from compress application
timeFrame: 3 weeks
measure: Improvement in patient reported outcome measures
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Department of Dermatology, Chair
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: