Skin ToxicityImmunoSkinNCT04929834
Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities
A study testing Hydrating emollient + body lotion for immunotherapy-related side effects in people with Skin Toxicity and Immunotoxicity, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Toxicity, Immunotoxicity
- What is being tested?
- Hydrating emollient + body lotion for immunotherapy-related side effects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jolien Robijns, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Jessa Ziekenhuis VZW
Hasselt, Limburg, 3500
Jeroen Mebis, MD, PhD, +32 11 33 72 21, Jeroen.mebis@jessazh.be
Jolien Robijns, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Hydrating emollient + body lotion for immunotherapy-related side effects
- Keywords
- Immunotherapy, Oncology, Skin, Skin reactions, Skincare
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrating emollient + body lotion for immunotherapy-related side effectsOther
Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All patients will receive the experimental emollients during 3 weeks. Receives: Other: Hydrating emollient + body lotion for immunotherapy-related side effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 3 of immunotherapy (end of study)
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline
Quality of life -DLQI
Dermatology Life Quality Index (DLQI) a questionnaire with 10 items and is used to measure QoL of dermatological patients.
Measured: 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.
Measured: Baseline
Quality of life - Skindex-29
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions.
Measured: 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.
Measured: Week 3 of immunotherapy (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start20 Oct 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University
- Responsible party
- Sponsor
- Investigators
- Jeroen Mebis, MD, PhD, Principal investigator, Jessa Ziekenhuis VZW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929834
- Sponsor's protocol ID
- 2021/059
- Acronym
- ImmunoSkin
- Status last verified
- Feb 2023
- First submitted
- 11 Jun 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities
- ClinicalTrials.gov ID
- NCT04929834
- Acronym / sponsor ID
- ImmunoSkin / 2021/059
- Conditions
- Skin Toxicity, Immunotoxicity
- Keywords
- Immunotherapy, Oncology, Skin, Skin reactions, Skincare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Collaborators
- Hasselt University
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Hydrating emollient + body lotion for immunotherapy-related side effectsAll patients will receive the experimental emollients during 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrating emollient + body lotion for immunotherapy-related side effectsHydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions | Other | Experimental group |
Primary outcome
Skin reaction evaluation
Time frame: 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
Time frame: 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
Time frame: Baseline
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.
Patient benefit composite
Time frame: 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: 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.
9 secondary outcomes
Patient subjective evaluation of skin reactions
Time frame: Baseline
Patient subjective evaluation of skin reactions
Time frame: Week 1 of immunotherapy
Patient subjective evaluation of skin reactions
Time frame: Week 2 of immunotherapy
Patient subjective evaluation of skin reactions
Time frame: Week 3 of immunotherapy (end of study)
Quality of life -DLQI
Time frame: Baseline
Quality of life -DLQI
Time frame: Week 3 of immunotherapy (end of study)
Quality of life - Skindex-29
Time frame: Baseline
Quality of life - Skindex-29
Time frame: Week 3 of immunotherapy (end of study)
Patients' satisfaction with the therapeutic intervention
Time frame: Week 3 of immunotherapy (end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolien Robijns, PhD contact
Jeroen Mebis, MD, PhD principal investigator
Jessa Ziekenhuis VZW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrating emollient + body lotion for immunotherapy-related side effects in people with Skin Toxicity and Immunotoxicity, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Mebis, MD, PhD (+32 11 33 72 21, Jeroen.mebis@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin reaction evaluation (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.