Novel Skin Care for Chemotherapy- Related Dermatologic Toxicities
- Conditions
- Skin Toxicity
- Interventions
- Other: Self-prepared emollient
- Registration Number
- NCT04929847
- Lead Sponsor
- Jessa Hospital
- 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 chemotherapeutic agents. The chemotherapy-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 ChemoSkin project, a novel emollient to tackle the cutaneous adverse events of chemotherapy has been developed.
The ChemoSkin project general aim is to evaluate the efficacy of a novel skincare product to manage chemotherapy-related cutaneous toxicities.
- Detailed Description
Primary objective Evaluate the efficacy of a novel emollient for the management of chemotherapy-related cutaneous adverse events
Secondary objective 1 Evaluate patient-relevant treatment benefit of the novel emollient for chemotherapy-associated cutaneous toxicities
Secondary objective 2 Evaluate the influence of the novel emollient for chemotherapy- associated cutaneous toxicities on the patient's quality of life
Secondary objective 3 Evaluate the safety of the novel emollient for chemotherapy- associated cutaneous toxicities
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Diagnosed with cancer of any type
- Undergoing chemotherapy at the Jessa Hospital (Hasselt, BE)
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 Self-prepared emollient All patients will receive the experimental emollient during 3 weeks.
- Primary Outcome Measures
Name Time Method Skin reaction evaluation Week 3 of chemotherapy (End of study) The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.
Patient benefit composite Week 3 of chemotherapy (end of study) The 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.
- Secondary Outcome Measures
Name Time Method Patient subjective evaluation of skin reactions Week 3 of chemotherapy (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 - Skindex-29 Week 3 of chemotherapy (end of study) The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Quality of life - DLQI Week 3 of chemotherapy (end of study) Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.
Patients' satisfaction with the therapeutic intervention Week 3 of chemotherapy (end of study) The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products by using a numerical rating scale.
Trial Locations
- Locations (1)
Jessa Ziekenhuis VZW
🇧🇪Hasselt, Limburg, Belgium