Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04929808
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2021-06-11
Brief Title:
Novel Skin Care Product for the Management of Acute Radiodermatitis
Sponsor:
Jessa Hospital
Organization:
Jessa Hospital
Study Overview
Official Title:
Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RTSkin
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 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None