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

Sponsor

Stratpharma AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05450848

Collaborator

(none)

200

Enrollment

Locations

Arms

66.9

Anticipated Duration (Months)

100

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Dermatitis	Device: StrataXRT Other: Sorbolene	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Active Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months]
Radiation dermatitis reaction as assessed by blinded assessment of digital photographs using the CTCAE v4.0 radiation dermatitis grades. CTCAE v4.0 severity grades are categorical with 5 possible categories (1, 2, 3, 4, 5). Grade 1 represents the weakest form of radiation dermatitis. Higher CTCAE Grades represent increasing radiation dermatitis severity.
Radiation induced skin reaction assessment scale (RISRAS) [From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months]
Radiation dermatitis reaction as assessed by the clinician during patient consultations using the eviQ RISRAS form. RISRAS scale is continuous scale from 0 to 36, with higher RISRAS scores representing higher severity of radiation dermatitis.

Secondary Outcome Measures

Onset of radiation dermatitis [From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months]
Timepoint of onset of CTCAE v4.0 radiation dermatitis Grades 2 and/or 3 during or after radiotherapy.
Length of time until resolution of radiation dermatitis [From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months]
Length of time from peak incidence to resolution of radiation dermatitis.
Patient reported symptoms treatment [From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months]
Patient reported comfort scale obtained using the eviQ RISRAS form.
Cost-effectiveness [From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months]
The mean total cost of skin care per patient.
Incidence of late-effects skin toxicity [3 - 12 months post radiation treatment]
The late skin toxicity post-radiotherapy assessed using the Radiation Therapy Oncology Group (RTOG) grading definitions: Grade 0: No change over baseline Grade I: Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating Grade II: Tender or bright erythema, patchy moist desquamation, moderate oedema Grade III: Confluent, moist desquamation other than skin folds, pitting oedema Grade IV: Ulceration haemorrhage, necrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Townsville Cancer Center, Townsville Hospital and Health Service	Douglas	Queensland	Australia	4814
2	Princess Alexandra Hospital	South Brisbane	Queensland	Australia	4101

Sponsors and Collaborators

Stratpharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stratpharma AG

ClinicalTrials.gov Identifier:

NCT05450848

Other Study ID Numbers:

SPASX01AU002

First Posted:

Jul 11, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis

Radiodermatitis

Study Results

No Results Posted as of Jul 11, 2022