Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities

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 immunomodulatory agents. The immunotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival. 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 ImmunoSkin project, two novel skin care products to tackle the cutaneous adverse events of immunotherapy have been developed. The ImmunoSkin project general aim is to evaluate the efficacy of two novel skincare products to manage immunotherapy-related cutaneous toxicities.

Detailed Description
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Primary objective Evaluate the efficacy of two novel skin care products for the management of immunotherapy-related cutaneous adverse events Secondary objective 1 Evaluate patient-relevant treatment benefit of two novel skin care products for immunotherapy-related cutaneous toxicities Secondary objective 2 Evaluate the influence of two novel skin care products for immunotherapy-related cutaneous toxicities on the patient's quality of life Secondary objective 3 Evaluate the safety of two novel skin care products for immunotherapy-related cutaneous toxicities

Official Title
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Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities

Conditions
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Skin Toxicity, Immunotoxicity

Intervention / Treatment
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* Other: Hydrating emollient + body lotion for immunotherapy-related side effects


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with cancer of any type Undergoing immunotherapy, check point inhibitors, at the Jessa Hospital (Hasselt, BE) Age ≥ 18 years Able to comply to the study protocol Able to sign written informed consent Exclusion Criteria: Pre-existing skin rash, ulceration, skin infections or open wounds Severe psychological disorder or dementia 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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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>All patients will receive the experimental emollients during 3 weeks. | Other: Hydrating emollient + body lotion for immunotherapy-related side effects<br>* Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reaction evaluation | The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) will be used to evaluate the skin reactions in the cancer patients | Baseline | 
| Skin reaction evaluation | The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) will be used to evaluate the skin reactions in the cancer patients | Week 3 of immunotherapy (end of study) | 
| Patient benefit composite | Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components: Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective. | Baseline | 
| Patient benefit composite | Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components: Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective. | Week 3 of immunotherapy (end of study) | 

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 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 of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Week 1 of immunotherapy | 
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Week 2 of immunotherapy | 
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Week 3 of immunotherapy (end of study) | 
| Quality of life -DLQI | Dermatology Life Quality Index (DLQI) a questionnaire with 10 items and is used to measure QoL of dermatological patients. | Baseline | 
| Quality of life -DLQI | Dermatology Life Quality Index (DLQI) a questionnaire with 10 items and is used to measure QoL of dermatological patients. | Week 3 of immunotherapy (end of study) | 
| Quality of life - Skindex-29 | The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. | Baseline | 
| Quality of life - Skindex-29 | The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. | Week 3 of immunotherapy (end of study) | 
| 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 using a numerical rating scale. | Week 3 of immunotherapy (end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Oncology, Skin, Skin reactions, Skincare