StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2023-03-31

Brief Summary

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Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.

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Detailed Description

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Conditions

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Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Site investigators will load the digital photographs taken at each weekly assessment into each participant's MOSAIQ record. They will then send de-identified copies to the Central Trial Coordinator who will distribute them to the study investigators who will be performing the blinded assessment. Each weekly photograph will be independently assessed by two study investigators using the CTCAE 4.0 scale for radiation dermatitis (Appendix 1). The study investigators will complete the supplied photograph assessment form and return them to the Central Trial Coordinator.

Study Groups

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StrataXRT

Patients allocated to receive StrataXRT will be provided with StrataXRT gel to apply twice daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided.

Group Type EXPERIMENTAL

StrataXRT

Intervention Type DEVICE

StrataXRT is a flexible wound dressing for the prevention and treatment of radiation dermatitis. It is in the form of a gel which, when applied, creates a protective film that maintains skin integrity. The product is used to relieve low grade inflammatory radiation changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes with open wound components, StrataXRT reduces pain, redness and heat and helps soothe the exposed skin areas. StrataXRT can be applied where skin integrity has been compromised and may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains Polydimethylsiloxanes, Siloxanes and Alkylmethyl Silicones and is transparent and odourless. It does not contain alcohols, parabens or fragrances. StrataXRT can be used with or without a secondary protective dressing. It is suitable for children and people with sensitive skin.

Standard of care

Patients allocated to receive standard care will be provided with aqueous cream to apply daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided.

Group Type ACTIVE_COMPARATOR

Sorbolene

Intervention Type OTHER

Aqueous cream (moisturizer) that soothes itchiness and dryness of the skin, and aids skin hydration. It is non-greasy, fragrance free, colour free, GMO free, paraben free and pH balanced.

Interventions

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StrataXRT

StrataXRT is a flexible wound dressing for the prevention and treatment of radiation dermatitis. It is in the form of a gel which, when applied, creates a protective film that maintains skin integrity. The product is used to relieve low grade inflammatory radiation changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes with open wound components, StrataXRT reduces pain, redness and heat and helps soothe the exposed skin areas. StrataXRT can be applied where skin integrity has been compromised and may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains Polydimethylsiloxanes, Siloxanes and Alkylmethyl Silicones and is transparent and odourless. It does not contain alcohols, parabens or fragrances. StrataXRT can be used with or without a secondary protective dressing. It is suitable for children and people with sensitive skin.

Intervention Type DEVICE

Sorbolene

Aqueous cream (moisturizer) that soothes itchiness and dryness of the skin, and aids skin hydration. It is non-greasy, fragrance free, colour free, GMO free, paraben free and pH balanced.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with cancer undergoing a curative course of radiation therapy using standard protocols to the following cancer sites:

* Head and neck cancers receiving \>= 60Gy who are not receiving concurrent Cetuximab
* Intact breast receiving \>= 40Gy (includes patients receiving boost fields using photon or elections)
* Post-mastectomy chest wall (breast cancer diagnosis only) receiving \>= 50Gy
* Gynaecological cancers requiring whole pelvis irradiation receiving \>= 45Gy
* Skin cancers to the axilla/groin regions receiving \>= 40Gy
* Male and female patients \>18 years of age
* Patients who do not have a known allergy to silicon
* Patients who are able to attend the four post-treatment weekly skin assessment appointments

Exclusion Criteria

Ineligible participants are patients undergoing a course of curative radiation therapy:

* Who are participating in another interventional study
* With an allergy to product content (standard or StrataXRT)
* With an existing skin rash, ulceration or open wound in the treatment area
* With a pre-existing systemic skin disease (dermatological conditions, connective tissue disorders)
* Who have had previous radiation therapy to the current treatment area
* Who are on immuno-suppression drugs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No