NCT04929808

Novel Skin Care Product for the Management of Acute Radiodermatitis

Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: Female
• 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 radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT. 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 RTskin project, a novel emollient to tackle ARD has been developed. The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.

Detailed description

Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care. Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care. Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics

Conditions

• Radiodermatitis; Acute
• Radiation Dermatitis

Interventions

Type	Name	Description
OTHER	Hydrating emollient for acute radiodermatitis	The emollient has a calming effect, and hydrating and anti-oxidative properties. An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.
OTHER	Standard institutional skin care	The control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-06-13
• Completion: 2023-06-13
• First posted: 2021-06-18
• Last updated: 2023-07-13

Locations

1 site across 1 country: Belgium