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

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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Device: StrataXRT; Other: Sorbolene

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Townsville Cancer Center, Townsville Hospital and Health Service
    • South Brisbane, Queensland, Australia, 4101
      • Princess Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Common Terminology Criteria for Adverse Events (CTCAE) v4.0	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.	From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Radiation induced skin reaction assessment scale (RISRAS)	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.	From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of radiation dermatitis	Timepoint of onset of CTCAE v4.0 radiation dermatitis Grades 2 and/or 3 during or after radiotherapy.	From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Length of time until resolution of radiation dermatitis	Length of time from peak incidence to resolution of radiation dermatitis.	From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Patient reported symptoms treatment	Patient reported comfort scale obtained using the eviQ RISRAS form.	From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Cost-effectiveness	The mean total cost of skin care per patient.	From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Incidence of late-effects skin toxicity	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	3 - 12 months post radiation treatment

Collaborators and Investigators

• Sponsor: Stratpharma AG

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: SPASX01AU002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No