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Trial Title:
M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis
NCT ID:
NCT06441266
Condition:
Radiation Dermatitis
Conditions: Official terms:
Head and Neck Neoplasms
Dermatitis
Radiodermatitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
KeraStat cream
Description:
KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended
to act as a protective covering in the management of a variety of skin conditions. The
intervention is a topical cream applied at least twice daily starting at start of
radiation therapy until 1-month from the end of radiation therapy completion
Arm group label:
M-PART Assessment via MyCap
Intervention type:
Device
Intervention name:
M-PART Assessments via MyCap
Description:
The M-PART approach harnesses the remote data collection capabilities of MyCap to
facilitate remote collection or data including but not limited to toxicity assessments,
quality of life surveys, and patient-provided photographs of the skin in the treated area
Arm group label:
M-PART Assessment via MyCap
Intervention type:
Other
Intervention name:
Clinical Assessments
Description:
Participants will undergo assessments at baseline (prior to radiation therapy start),
weekly during and after radiation therapy until 1-month post-radiation therapy. Medical
history will be collected at baseline including primary cancer site, HPV status (if
oropharyngeal cancer primary), laterality, TNM classification, stage, surgical resection
prior to radiation therapy, weight, body mass index and patient self-reported Fitzpatrick
skin phototype.
Arm group label:
M-PART Assessment via MyCap
Intervention type:
Other
Intervention name:
Feedback phone interview
Description:
Participant satisfaction, perceptions and preferences with using M-PART will be
discussed.
Arm group label:
M-PART Assessment via MyCap
Summary:
The purpose of this research study is to test the ability of a mobile device application
(MyCap) to collect patient information about their radiation skin rash in patients with
head and neck cancer being treated with radiation therapy.
Detailed description:
Primary Objective: To determine the feasibility of M-PART for the assessment of acute
radiation dermatitis in patients treated with radiotherapy for head and neck cancer via
MyCap.
Secondary Objectives:
- To assess agreement between site clinician-rated CTCAE G2+ radiation dermatitis with
moist desquamation and patient-reported moist desquamation (a and b above).
- To assess the proportion of patient-submitted photographs of skin in the irradiated
area that are evaluable for radiation dermatitis assessments by central review.
- To assess agreement between clinician-rated radiation dermatitis grading, central
review of patient-submitted photographs, and central review of standardized clinic
photographs (methods a, c, and d above).
- To measure the level of interval (i.e., optional engagement in between scheduled
collection) patient engagement in the collection of radiation toxicity outcomes
using the M-PART methodology.
- To measure patient and research staff satisfaction, perceptions, and preferences
with regard to the M-PART data collection framework.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histological or cytological diagnosis of head and neck cancer (of any part of the
oral cavity, pharynx, larynx, or sinuses) planned to receive conventionally
fractionated radiation therapy (RT) targeting the head and neck to a total
prescribed dose of at least 60 Gy. The 60 Gy RT target must include at least a part
of the unilateral and/or bilateral lymph node regions of the head/neck. Planned
prescribed dose will be reviewed and approved by the study PI.
NOTE: Patients without a clear pathologic diagnosis of invasive disease (i.e., biopsy
showing at least carcinoma in situ) but with clinically diagnosed head and neck cancer
planned for treatment as above are also eligible.
- Age ≥ 18 years at the time of enrollment.
- Able and willing to complete electronic toxicity and quality of life assessments in
the MyCap application using their personal mobile device.
- Ability to understand and the willingness to sign an IRB-approved informed consent
document (either directly or via a legally authorized representative) in English.
Exclusion Criteria:
- Early stage (Stage I-II) squamous cell carcinoma of the glottic larynx planned for
treatment with limited field radiation therapy alone. These participants are
excluded since they are expected to receive a more limited exposure to radiation
therapy.
- Patients planned for treatment to the primary site alone without regional lymph node
targeting.
- Previous radiation therapy to the area in the head and neck to be treated with
radiation therapy.
- Active use of topical corticosteroids in the irradiation area at the time of
registration.
- History of scleroderma or active lupus requiring systemic medication at the time of
registration.
- Planned concurrent treatment with anti-EGFR biologic therapy (e.g., cetuximab) for
head and neck cancer.
- Individuals who are pregnant or plan to become pregnant. Radiotherapy is
contraindicated in this patient population.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wake Forest Baptist Comprehensive Cancer Center
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Contact:
Last name:
Principal Investigator
Phone:
336-713-3600
Email:
ryhughes@wakehealth.edu
Investigator:
Last name:
Ryan T. Hughes, MD
Email:
Principal Investigator
Start date:
November 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06441266
