Clinical trial NCT04929834: Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities
Official title: Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Toxicity
Immunotoxicity
Keywords: Immunotherapy
Oncology
Skin
Skin reactions
Skincare
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Hasselt University
First posted: 2021-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Skin reaction evaluation
timeFrame: Baseline
measure: Skin reaction evaluation
timeFrame: Week 3 of immunotherapy (end of study)
measure: Patient benefit composite
timeFrame: Baseline
measure: Patient benefit composite
timeFrame: Week 3 of immunotherapy (end of study)
Secondary outcomes:
measure: Patient subjective evaluation of skin reactions
timeFrame: Baseline
measure: Patient subjective evaluation of skin reactions
timeFrame: Week 1 of immunotherapy
measure: Patient subjective evaluation of skin reactions
timeFrame: Week 2 of immunotherapy
measure: Patient subjective evaluation of skin reactions
timeFrame: Week 3 of immunotherapy (end of study)
measure: Quality of life -DLQI
timeFrame: Baseline
measure: Quality of life -DLQI
timeFrame: Week 3 of immunotherapy (end of study)
measure: Quality of life - Skindex-29
timeFrame: Baseline
measure: Quality of life - Skindex-29
timeFrame: Week 3 of immunotherapy (end of study)
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: Week 3 of immunotherapy (end of study)
Other outcomes:
measure: General patient-, disease-, and treatment-related information
timeFrame: Baseline
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis VZW
state: Limburg
Study officials:
affiliation: Jessa Ziekenhuis VZW
name: Jeroen Mebis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: