ImmunoSkin: Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Skin reaction evaluation [Baseline]
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
- Skin reaction evaluation [Week 3 of immunotherapy (end of study)]
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
- Patient benefit composite [Baseline]
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.
- Patient benefit composite [Week 3 of immunotherapy (end of study)]
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.
Secondary Outcome Measures
- Patient subjective evaluation of skin reactions [Baseline]
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
- Patient subjective evaluation of skin reactions [Week 1 of immunotherapy]
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
- Patient subjective evaluation of skin reactions [Week 2 of immunotherapy]
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
- Patient subjective evaluation of skin reactions [Week 3 of immunotherapy (end of study)]
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
- Quality of life -DLQI [Baseline]
Dermatology Life Quality Index (DLQI) a questionnaire with 10 items and is used to measure QoL of dermatological patients.
- Quality of life -DLQI [Week 3 of immunotherapy (end of study)]
Dermatology Life Quality Index (DLQI) a questionnaire with 10 items and is used to measure QoL of dermatological patients.
- Quality of life - Skindex-29 [Baseline]
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions.
- Quality of life - Skindex-29 [Week 3 of immunotherapy (end of study)]
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions.
- Patients' satisfaction with the therapeutic intervention [Week 3 of immunotherapy (end of study)]
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.
Other Outcome Measures
- General patient-, disease-, and treatment-related information [Baseline]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with cancer of any type
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Undergoing immunotherapy, check point inhibitors, at the Jessa Hospital (Hasselt, BE)
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Age ≥ 18 years
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Able to comply to the study protocol
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Able to sign written informed consent
Exclusion Criteria:
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Pre-existing skin rash, ulceration, skin infections or open wounds
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Severe psychological disorder or dementia
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Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jessa Ziekenhuis VZW | Hasselt | Limburg | Belgium | 3500 |
Sponsors and Collaborators
- Jessa Hospital
- Hasselt University
Investigators
- Principal Investigator: Jeroen Mebis, MD, PhD, Jessa Ziekenhuis VZW
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/059