Novel Skin Care Product for the Management of Acute Radiodermatitis

Study Overview
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Brief Summary
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Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT. Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed. The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.

Detailed Description
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Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care. Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care. Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics

Official Title
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Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients

Conditions
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Radiodermatitis; Acute, Radiation Dermatitis

Intervention / Treatment
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* Other: Hydrating emollient for acute radiodermatitis
* Other: Standard institutional skin care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of breast cancer and underwent lumpectomy or mastectomy Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE) Age ≥ 18 years Able to comply to the study protocol Able to sign written informed consent Signed written informed consent Exclusion Criteria: Previous irradiation to the breast region Metastatic disease Patients with pre-existing skin rash, ulceration or open wound in the treatment area Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Will receive the standard institutional skin care for acute radiodermatitis | Other: Standard institutional skin care<br>* The control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.<br>|
| Experimental: Experimental group<br>Will receive the novel, self-prepared skin care product | Other: Hydrating emollient for acute radiodermatitis<br>* The emollient has a calming effect, and hydrating and anti-oxidative properties. An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reaction evaluation | The patients skin reactions will be evaluated by the modified version of the RTOG criteria | Baseline | 
| Skin reaction evaluation | The patients skin reactions will be evaluated by the modified version of the RTOG criteria | At fraction 15-16 of radiotherapy (week 3 ) | 
| Skin reaction evaluation | The patients skin reactions will be evaluated by the modified version of the RTOG criteria | At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Baseline | 
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Week 1 of radiotherapy | 
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Week 2 of radiotherapy | 
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | At fraction 15/16 of radiotherapy (week 3) | 
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost | 
| Quality of life assessment | The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items). | Baseline | 
| Quality of life assessment | The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items). | At fraction 15/16 of radiotherapy (week 3) | 
| Quality of life assessment | The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items). | At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost | 
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS). | At fraction 15/16 of radiotherapy (week 3) | 
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS). | At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost | 
| Pruritus evaluation | The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria | Baseline | 
| Pruritus evaluation | The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria | At fraction 15/16 of radiotherapy (week 3) | 
| Pruritus evaluation | The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria | At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin toxicity, Radiotherapy, Oncology, Skin care, Emollient