Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03910595
Other study ID # 294-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2019
Est. completion date September 8, 2020

Study information

Verified date October 2020
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In patients undergoing adjuvant radiotherapy for breast cancer, radiation-induced skin toxicities are a common occurrence and adversely impact patients' quality of life (QOL). In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Recently, a phase III randomized trial by Herst et al. (n=78) in New Zealand showed that the prophylactic use of Mepitel Film reduced skin reaction severity by 92% compared to skin treated only with aqueous cream. Mepitel film has not been widely adopted in North America. To validate the efficacy of the film and guide the development of a larger multi-centre phase II study, a pilot study testing the efficacy of the film is proposed. In the study, 30 patients will have the film applied on their breast for the duration of radiation treatment and their skin reactions will be assessed throughout the treatment and after the treatment. The investigators hypothesize that the severity and incidence rates of skin reactions for patients using Mepitel film will be lower when compared to real world data from our centre, and that cosmetic outcomes will be improved with the film.


Description:

In patients undergoing adjuvant radiotherapy for breast cancer, radiation-induced skin toxicities are a common occurrence and adversely impact patients' quality of life (QOL). Patients with large breasts or patients receiving chest wall radiation may be more likely to have worse skin reactions following radiation. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Recently, a phase III randomized trial by Herst et al. (n=78) in New Zealand showed that the prophylactic use of Mepitel Film prevented moist desquamation (26% vs. 0%, p < 0.001) and reduced skin reaction severity by 92% (p < 0.001) compared to skin treated only with aqueous cream. Another study by Moller et al. (n=101) in Denmark reported a non-significant improvement in observer-rated radiation dermatitis with the film (p=0.1) compared to cream, and significant improvements in several patient-reported outcomes. Moreover, patients with breast cancer complain of hyperpigmentation in the radiated area during and after radiation. Mepitel Film has not been widely adopted in North American clinical practice. To further study and validate the efficacy of Mepitel Film in preventing acute skin reactions caused by breast radiation and elucidate its efficacy in preventing poor cosmetic outcomes, a phase II efficacy study of three patient populations will be conducted: 1. Patients with large breasts 2. Patients with small or medium sized breasts 3. Patients with chest wall radiation The results of the phase II efficacy study can guide the development of a subsequent multi-centre phase II and III trials to further validate the use of Mepitel film and increase its adoption rate. The primary objective is to examine the efficacy of Mepitel film in the prophylaxis of radiation-induced skin reactions. Secondary objectives include an evaluation of patient-reported and healthcare professional (HCP)-reported skin toxicities including moist desquamation with the use of Mepitel film. Radiation oncologists will first introduce the study to their patients in their breast clinic, showing a sample of the product and also pictures from the trial conducted in New Zealand. Patients if interested may be provided a patient information sheet to review at home. Then, patients will be approached by a CRA at their radiation planning appointment to review all information and obtain informed consent. All patients will receive Mepitel film for the duration of treatment. Radiation treatment will be delivered as prescribed by the treating radiation oncologist and may include a variety of techniques and beam modifiers. Trained clinical research assistants (CRA) or the radiation review nurse will apply the Mepitel film for patients prior to their first radiation treatment at a designated clinic room and will check daily prior to radiation that the breast/chest wall has not been distorted by the film. If the film needs to be readjusted, the CRAs or nurses will remove peeling sections of film and reapply where needed. The film will be removed two weeks post radiation treatment. Patients will complete evaluations once a week at their regular review clinic visit and will be assessed by an HCP or CRA. At the last treatment or last review appointment, a photo of the patient's breasts/chest wall will be taken, and they will be asked to complete an assessment. An HCP will also conduct an assessment. After completion of radiation, patients will be called at week 1 and weeks 3-6 to assess endpoints. Patients will be asked to return for a 2-week, 3-month, and 6-month follow-up assessment where photos of their breasts/chest wall will be taken, and they will complete their personal assessments. The film will be removed at the 2-week follow-up appointment. The 3-month follow-up assessment will occur at the same time as their regular clinic follow-up with their radiation oncologist. At the 3-month and 6-month follow-up assessment, an HCP will also an assessment.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 8, 2020
Est. primary completion date April 28, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent - Patient will receive adjuvant breast or chest wall radiation - Post-lumpectomy patients with band size of at least 36 inches or cup size of D or larger will be part of the large breast cohort - Post-lumpectomy patients that do not meet this size requirement will be part of the small or medium sized breast cohort - Post-mastectomy patients are part of the chest wall radiation cohort - Can communicate in English or be aided by a hospital translator Exclusion Criteria: - Patient had previous radiation therapy to the treatment area - Patient had breast reconstruction - Patient has a Karnofsky Performance Status score <70 - Patient will have radiation treatment in prone or reverse decubitus positions - Patient will receive partial breast external beam radiation or brachytherapy - Patient will receive radiation to the supraclavicular region

Study Design


Intervention

Other:
Mepitel Film
Mepitel film is a barrier film that may help in reducing radiation dermatitis by limiting friction.

Locations

Country Name City State
Canada Odette Cancer Centre, Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Observable differences between treated and non-treated breasts/chest wall Determined by a cosmetic dermatologist from photographs of the treated and non-treated breast/chest wall. Within 3 months following radiation
Secondary Patient reports of acute skin toxicity Measured by the Skin Symptom Assessment (SSA); subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much" Within 3 months following radiotherapy
Secondary Patient reports of late skin toxicity Measured by the SSA; subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much" 6 months following radiotherapy
Secondary Clinician reports of acute skin toxicity Measured by the SSA; subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much" Within 3 months following radiotherapy
Secondary Clinician reports of late skin toxicity Measured by the SSA; subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much" 6 months following radiotherapy
Secondary Clinician grading of acute skin toxicity Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE); graded on a scale from 0 (best) to 4 (worst) Within 3 months following radiotherapy
Secondary Clinician grading of late skin toxicity Measured by the NCI CTCAE; graded on a scale from 0 (best) to 4 (worst) 6 months following radiotherapy
Secondary Degree of acute skin toxicity and interference with daily functioning Measured by the Radiation Induced Skin Reaction Assessment System (RISRAS); researcher subscales for erythema and dry desquamation rated from 0 (best) to 4 (worst); researcher subscale for moist desquamation rated from 0 (best) to 6 (worst); researcher subscale for necrosis rated from 0 (best) to 10 (worst); patient subscales for tenderness/discomfort/pain, itchiness, burning sensation, and interference with daily activities rated from 0 (best) to 3 (worst). Within 3 months following radiotherapy
Secondary Degree of late skin toxicity and interference with daily functioning Measured by the RISRAS; researcher subscales for erythema and dry desquamation rated from 0 (best) to 4 (worst); researcher subscale for moist desquamation rated from 0 (best) to 6 (worst); researcher subscale for necrosis rated from 0 (best) to 10 (worst); patient subscales for tenderness/discomfort/pain, itchiness, burning sensation, and interference with daily activities rated from 0 (best) to 3 (worst). 6 months following radiotherapy
Secondary Long-term changes in skin pigmentation Measured by photographs of the treated and non-treated breast and graded by a cosmetic dermatologist Changes from baseline to 6 months following radiotherapy
Secondary Acute changes in breast cosmesis Measured by the European Organization for Research and Treatment of Cancer (EORTC) Breast Cosmetic Rating System; subscales for breast size, breast shape, location of areola/nipple, shape of areola/nipple, tanning, pallor, breast edema, appearance of scar, and telangiectasia graded from 0 (best) to 3 (worst); overall grade assigned from 0 (best) to 2 (worst). Within 3 months following radiotherapy
Secondary Late changes in breast cosmesis Measured by the EORTC Breast Cosmetic Rating System; subscales for breast size, breast shape, location of areola/nipple, shape of areola/nipple, tanning, pallor, breast edema, appearance of scar, and telangiectasia graded from 0 (best) to 3 (worst); overall grade assigned from 0 (best) to 2 (worst). 6 months following radiotherapy
Secondary Film Integrity Assessment Evaluated daily prior to the patient's radiotherapy treatment Until film is removed, 2 weeks following radiotherapy
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2