NCT04929847

Novel Skin Care for Chemotherapy- Related Dermatologic Toxicities

Evaluation of a Novel Skin Care Product for the Management of Chemotherapy- Related Dermatologic Toxicities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Skin Toxicity

Interventions

Type	Name	Description
OTHER	Self-prepared emollient	The emollient is hypo-allergenic, free of perfume and has very high hydrating capacities together with antioxidants.

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-06-18
• Last updated: 2023-03-01

Locations

1 site across 1 country: Belgium