Novel Skin Care Product for the Management of Acute Radiodermatitis

NCT ID: NCT04929808

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-06-13

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group

Will receive the standard institutional skin care for acute radiodermatitis

Group Type: ACTIVE_COMPARATOR

Standard institutional skin care

Intervention Type: OTHER

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.

Experimental group

Will receive the novel, self-prepared skin care product

Group Type: EXPERIMENTAL

Hydrating emollient for acute radiodermatitis

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of breast cancer and underwent lumpectomy or mastectomy
• Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE)
• Age ≥ 18 years
• Able to comply to the study protocol
• Able to sign written informed consent
• Signed written informed consent

Exclusion Criteria

• Previous irradiation to the breast region
• Metastatic disease
• Patients with pre-existing skin rash, ulceration or open wound in the treatment area
• Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen Mebis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa ziekenhuis VZW

Locations

Jessa Ziekenhuis VZW

Hasselt, Limburg, Belgium

Countries

Belgium

References

Robijns J, Van Bever L, Hermans S, Claes M, Lodewijckx J, Lenaerts M, Tuts L, Vandaele E, Vinken E, Noe L, Verboven K, Maes A, Van de Velde AS, Bulens P, Bulens P, Van den Bergh L, Mebis J. A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial. Support Care Cancer. 2023 Oct 11;31(12):625. doi: 10.1007/s00520-023-08096-5.

Reference Type: DERIVED

PMID: 37819539 (View on PubMed)

Other Identifiers

2021/058

Identifier Type: -

Identifier Source: org_study_id