Clinical trial NCT05450848: StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Official title: A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
measure: Radiation induced skin reaction assessment scale (RISRAS)
timeFrame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary outcomes:
measure: Onset of radiation dermatitis
timeFrame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
measure: Length of time until resolution of radiation dermatitis
timeFrame: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
measure: Patient reported symptoms treatment
timeFrame: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
measure: Cost-effectiveness
timeFrame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
measure: Incidence of late-effects skin toxicity
timeFrame: 3 - 12 months post radiation treatment
Other outcomes:
Locations:
city: Douglas
country: Australia
facility: Townsville Cancer Center, Townsville Hospital and Health Service
state: Queensland
city: South Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
References: