Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities

NCT04929834 | Unknown

• 1 other identifier: 2021/059
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Toxicity; Immunotoxicity

Keywords

Immunotherapy; Oncology; Skin; Skin reactions; Skincare

Outcome Measures

Primary Outcomes (4)

• 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: 1. Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective. 2. 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: 1. Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective. 2. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective.

  Week 3 of immunotherapy (end of study)

Secondary Outcomes (9)

• Patient subjective evaluation of skin reactions

  Baseline

• Patient subjective evaluation of skin reactions

  Week 1 of immunotherapy

• Patient subjective evaluation of skin reactions

  Week 2 of immunotherapy

• Patient subjective evaluation of skin reactions

  Week 3 of immunotherapy (end of study)

• Quality of life -DLQI

  Baseline

Other Outcomes (1)

• General patient-, disease-, and treatment-related information

  Baseline

Study Arms (1)

Experimental group

EXPERIMENTAL

All patients will receive the experimental emollients during 3 weeks.

Other: Hydrating emollient + body lotion for immunotherapy-related side effects

Interventions

Hydrating emollient + body lotion for immunotherapy-related side effects OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead
• Hasselt University: collaborator

Study Sites (1)

Jessa Ziekenhuis VZW

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jeroen Mebis, MD, PhD

  Jessa Ziekenhuis VZW

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Mebis, MD, PhD

CONTACT

+32 11 33 72 21; Jeroen.mebis@jessazh.be

Jolien Robijns, PhD

CONTACT

jolien.robijns@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: October 20, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)