Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities

NCT ID: NCT04929834

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2023-12-31

Brief Summary

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

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

Conditions

Skin Toxicity; Immunotoxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group

All patients will receive the experimental emollients during 3 weeks.

Group Type: EXPERIMENTAL

Hydrating emollient + body lotion for immunotherapy-related side effects

Intervention Type: OTHER

Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions

Interventions

Hydrating emollient + body lotion for immunotherapy-related side effects

Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen Mebis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Ziekenhuis VZW

Locations

Jessa Ziekenhuis VZW

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jeroen Mebis, MD, PhD

Role: CONTACT

Jeroen.mebis@jessazh.be

+32 11 33 72 21

Jolien Robijns, PhD

Role: CONTACT

jolien.robijns@uhasselt.be

Facility Contacts

Jeroen Mebis, MD, PhD

Role: primary

Jeroen.mebis@jessazh.be

+32 11 33 72 21

Other Identifiers

2021/059

Identifier Type: -

Identifier Source: org_study_id