Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Behaviors and Mental Disorders

Breast Neoplasms

Dermatitis

Radiodermatitis

Breast Diseases

Skin Diseases

Radiation Injuries

Quality of Life

This is a single-arm trial where all patients will receive the intervention of StrataXRT.

StrataXRT is a silicone-based film-forming topical gel that may help in reducing radiation dermatitis.

StrataXRT

Edward LW Chow, MBBS

For breast cancer patients undergoing adjuvant radiotherapy, radiation dermatitis (RD) is a common occurrence that can negatively impact patients' quality of life (QOL). RD often presents as erythema, pruritus, and/or edema and in more severe cases, skin breakage can occur, resulting in moist desquamation. StrataXRT is a silicone-based film-forming topical gel. Recent studies have shown the benefits of StrataXRT, but with mixed results. A recent randomized controlled trial published in 2022 found that in breast cancer patients (n=100), the use of StrataXRT significantly reduced the mean size of the radiation-induced dermatitis area (p=0.002) when compared to the control group. Additionally, another study (n=49) demonstrated significant differences in the Erythema Index (EI) (p=0.001) and Melanin Index (MI) (p=0.005) between StrataXRT compared to the use of Xderm, a moisturizer cream. To validate the finding of the previous studies a pilot study testing the efficacy of StrataXRT has been proposed. In this study, 50 patients will use Strata XRT on their breast/chest wall during radiation treatment. Their skin will be assessed throughout and post-treatment. Investigators hypothesize the severity of skin reactions will be less for patients using Strata XRT when compared to historical data from our centre.

For breast cancer patients undergoing adjuvant radiotherapy, radiation dermatitis (RD) is a common occurrence that can negatively impact patients' quality of life (QOL). RD often presents as erythema, pruritus, and/or edema and in more severe cases, skin breakage can occur, resulting in moist desquamation. StrataXRT is a silicone-based film-forming topical gel, intended to be self-applied by the patients. As a result of the product's film-forming property, the gel can also be applied to the axilla and supraclavicular area. Due to the more versatile method of application, it is also possible that this product would be feasible for patients with large breasts, and patients treated in the prone position. This gel has the potential to reduce RD in patients with large breasts and patients receiving regional radiation.

StrataXRT has been shown to be non-inferior to Mepitel Film, a silicone dressing, in the prevention of RD. A study compared the rates of moist desquamation and CTCAE scoring in 44 breast cancer patients. Half the breast was covered with Mepitel Film and the other half with StrataXRT. The results showed no significant differences in the rate of moist desquamation or severity of RD assessed on the CTCAE between groups. There have been two randomized control trials conducted that showed promising results using StrataXRT. One of the studies found that in breast cancer patients (n=100), the use of StrataXRT significantly reduced the mean size of the radiation-induced dermatitis area (p=0.002) when compared to the control group. Additionally, RD as scored by the CTCAE was found to be significantly more severe in the control group. Another randomized control trial (n=49) demonstrated significant differences in the Erythema Index (EI) (p=0.001) and Melanin Index (MI) (p=0.005) between StrataXRT compared to the use of Xderm, a moisturizer cream. The EI and MI are alternative methods of measuring RD, using electrochemical reflectance most often with a handheld spectrophotometer.

There is limited research available on the ability of StrataXRT to prevent RD, and the available research presents major limitations and variability across studies. Measurement tools are inconsistent, and even when the scales are the same across studies, there is significant variability in the results. Further StrataXRT has not been widely adopted in North America for the prevention of RD. Therefore to validate the efficacy of StrataXRT in the prevention of severe radiation dermatitis a feasibility study using five patient populations will be conducted:

1. Patients with large breasts (minimum of band size of 36 inches or cup size C) treated in the prone position-breast radiation only
2. Patients with large breasts (minimum of band size of 36 inches or cup size C) treated in the supine position---breast radiation only
3. Patients with locoregional breast radiation (any breast size)
4. Patients with local chest wall radiation alone
5. Patients with locoregional chest wall radiation

The results of the feasibility study can go on to guide the development of a large multi-center randomized controlled trial to further validate the use of StrataXRT and potentially increase the adoption rate in North America.

The primary objective is to evaluate the feasibility of StrataXRT in the prevention of RD. Secondary objectives will include patient- and clinician-reported skin reactions and the presence of moist desquamation with the use of StrataXRT. As well as patient QOL and patient and clinician satisfaction with StrataXRT.

Patients will be approached by clinical research assistants (CRA) at their planning appointment. Here the CRA will introduce the study and provide them with an information sheet to read. After all information has been reviewed if patients are interested the CRA will obtain consent. All patients will receive StrataXRT to use during their treatment. Radiation treatment will be delivered as prescribed by the treating radiation oncologist. A trained CRA will teach the patients how to apply the StrataXRT on their first day of treatment. The CRA will make sure the patients know how and where to apply the gel. Patients will be asked to self-apply the StrataXRT at least twice daily and record how many times a day they apply it using a diary given to them on their first day.

Once a week during patients' regular visits with their treating radiation oncologist, patients and clinicians will be asked to complete assessments. On the first and last day of treatment, a photo of the patient's breasts/chest wall will be taken. At their last treatment, they will also be asked to complete additional assessments.

After completing radiation treatment, patients will be called for the following 6 weeks to complete assessments. Patients will be asked to return for an in-person assessment for their 2-week follow-up, instead of a telephone follow-up. A photo of the breasts/chest wall will be taken at this appointment and both patients and clinicians will be asked to complete assessments. A telephone follow-up will also take place 6-months post radiation treatment.

All patients will receive the StrataXRT intervention. StrataXRT will be given to patients in one of five patient populations:

1. Patients with large breasts (minimum of band size of 36 inches or cup size C) treated in the prone position-breast radiation only
2. Patients with large breasts (minimum of band size of 36 inches or cup size C) treated in the supine position---breast radiation only
3. Patients with locoregional breast radiation (any breast size)
4. Patients with local chest wall radiation alone
5. Patients with locoregional chest wall radiation

A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients

A Pilot Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients Undergoing Adjuvant Radiotherapy

Measured by the Common Terminology Criteria for Adverse Events; graded on a scale from 0 (best) to 4 (worst) assessed by clinicians

Measured by the Skin Symptom Assessment; items include itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded on a four-point scale using "not at all", "a little", "quite a bit", or "very much"

Measured using a yes/no answered by clinicians

Measured by the Radiation Induced Skin Reaction Assessment System; 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).

Determined by photographs of the treated and non-treated breast/chest wall

Measured using the Skindex-16; measures if 16 different symptoms have bothered the patient on a scale of 0 to 6 (0=never bothered, 6=always bothered).

Measured using a patient satisfaction questionnaire

Measured using a constructed clinician satisfaction questionnaire

Measured using records of use of StrataXRT for each patient.

Sunnybrook Health Sciences Centre

Principal Investigator

Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.

Ivy Petersen, MD

To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.

Feasibility in the Prophylaxis of Radiation Dermatitis Severity

Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients

Patients will be asked to complete a survey at the end of study that will ask them to provide feedback on the agent used during their treatment.

Mayo Clinic

Dermatologic Agents

All Drugs and Chemicals

Petrolatum

Emollients

Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides.

Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy.

StrataXRT is a full contact flexible wound dressing for the prevention and treatment of radiation dermatitis. StrataXRT is a semi-occlusive, self-drying and transparent gel.

When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns.

Aquaphor is a brand of over-the-counter (OTC) skin care ointments manufactured by Beiersdorf Inc.

Aquaphor contains 41 percent petrolatum (or petroleum jelly), the active ingredient, temporarily protects minor cuts, scrapes, and burns; protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather.

Aquaphor

Carolina Rojas

The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.

StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy

The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions.

The amount of \> grade 2 RD cases will be compared in both study groups.

The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD. Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The repeated measurements average toxicity will be compared in both study groups.

The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD.Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The time to moist desquamation will be compared in both study groups.

The participant will be asked to rate their pain level at the irradiated area. The time of interest of the original VAS is modified from "the past 24 hours" to "the past 7 days" for the specific purpose of this study. The VAS has been selected as it is a brief and easy tool for the assessment of pain within both the clinical and research settings. It has been well validated in both the chronic pain and cancer settings. The scale of 0 to 10 is simple for patients to use and reflects common clinical assessment of pain.

Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.

Itching will be scored on a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine). Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients	NCT05594498	Breast Cancer Radiation Derma...	StrataXRT	18 Years -	Sunnybrook Health Sciences Centre
Feasibility in the Prophylaxis of Radiation Dermatitis Severity	NCT04715386	Radiation Derma...	StrataXRT	18 Years -	Mayo Clinic
Feasibility in the Prophylaxis of Radiation Dermatitis Severity	NCT04715386	Radiation Derma...	StrataXRT	18 Years -	Mayo Clinic
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis	NCT05553392	Radiation Derma...	StrataXRT Aquaphor	18 Years -	Stratpharma AG
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis	NCT05553392	Radiation Derma...	StrataXRT Aquaphor	18 Years -	Stratpharma AG

Spots Global Cancer Trial Database for strataxrt

Every month we try and update this database with for strataxrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for strataxrt

Every month we try and update this database with for strataxrt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for strataxrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.