Novel Skin Care Product for the Management of Acute Radiodermatitis

NCT04929808 | Completed

• 1 other identifier: 2021/058
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiodermatitis; Acute; Radiation Dermatitis

Keywords

Skin toxicity; Radiotherapy; Oncology; Skin care; Emollient

Outcome Measures

Primary Outcomes (3)

• Skin reaction evaluation

  The patients skin reactions will be evaluated by the modified version of the RTOG criteria

  Baseline

• Skin reaction evaluation

  The patients skin reactions will be evaluated by the modified version of the RTOG criteria

  At fraction 15-16 of radiotherapy (week 3 )

• Skin reaction evaluation

  The patients skin reactions will be evaluated by the modified version of the RTOG criteria

  At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost

Secondary Outcomes (13)

• Patient subjective evaluation of skin reactions

  Baseline

• Patient subjective evaluation of skin reactions

  Week 1 of radiotherapy

• Patient subjective evaluation of skin reactions

  Week 2 of radiotherapy

• Patient subjective evaluation of skin reactions

  At fraction 15/16 of radiotherapy (week 3)

• Patient subjective evaluation of skin reactions

  At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost

Other Outcomes (3)

• General patient-, disease-, and treatment-related information

  Baseline

• General patient-, disease-, and treatment-related information

  Week 4 of radiotherapy

• General patient-, disease-, and treatment-related information

  Two weeks post-radiotherapy (follow-up)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Will receive the standard institutional skin care for acute radiodermatitis

Other: Standard institutional skin care

Experimental group

EXPERIMENTAL

Will receive the novel, self-prepared skin care product

Other: Hydrating emollient for acute radiodermatitis

Interventions

Hydrating emollient for acute radiodermatitis 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.

Experimental group

Standard institutional skin care 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead
• Hasselt University: collaborator

Study Sites (1)

Jessa Ziekenhuis VZW

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37819539 DERIVED

MeSH Terms

Conditions

Radiodermatitis; Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Jeroen Mebis, MD, PhD

  Jessa ziekenhuis VZW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: February 1, 2022
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)