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Completed

NCT Number: NCT05450848

StrataXRT vs. 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.

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Key information

Conditions

Radiation Dermatitis Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Townsville Cancer Center, Townsville Hospital and Health Service, Douglas, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StrataXRT

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.

Sorbolene

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.

Primary outcomes

  1. Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    Time frame: 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.

  2. Radiation induced skin reaction assessment scale (RISRAS)

    Time frame: 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 outcomes

  1. Onset of radiation dermatitis

    Time frame: 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.

  2. Length of time until resolution of radiation dermatitis

    Time frame: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months

    Length of time from peak incidence to resolution of radiation dermatitis.

  3. Patient reported symptoms treatment

    Time frame: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months

    Patient reported comfort scale obtained using the eviQ RISRAS form.

  4. Cost-effectiveness

    Time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months

    The mean total cost of skin care per patient.

  5. Incidence of late-effects skin toxicity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Stratpharma AG

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2022
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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