Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities (ImmunoSkin)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Immunotoxicity; Skin Toxicity
• Intervention / Treatment: Other: Hydrating emollient + body lotion for immunotherapy-related side effects

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jolien Robijns, PhD; Email: jolien.robijns@uhasselt.be
• Study Contact Backup: Name: Jeroen Mebis, MD, PhD; Phone Number: +32 11 33 72 21; Email: Jeroen.mebis@jessazh.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Ziekenhuis VZW
      • Contact: Jeroen Mebis, MD, PhD; Phone Number: +32 11 33 72 21; Email: Jeroen.mebis@jessazh.be
      • Sub-Investigator: Jolien Robijns, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, dosing etc).	Baseline

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Collaborators: Hasselt University
• Investigators: Principal Investigator: Jeroen Mebis, MD, PhD, Jessa Ziekenhuis VZW

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Immunotherapy; Skin; Oncology; Skin reactions; Skincare
• Additional Relevant MeSH Terms: Dermatologic Agents; Emollients
• Other Study ID Numbers: 2021/059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No