Novel Skin Care Product for the Management of Acute Radiodermatitis

Overview

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.

Full Title of Study: “Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2023

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Control group
    • Will receive the standard institutional skin care for acute radiodermatitis
  • Experimental: Experimental group
    • Will receive the novel, self-prepared skin care product

Clinical Trial Outcome Measures

Primary Measures

  • Skin reaction evaluation
    • Time Frame: Baseline
    • The patients skin reactions will be evaluated by the The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.
  • Skin reaction evaluation
    • Time Frame: At fraction 16 of radiotherapy (week 3 )
    • The patients skin reactions will be evaluated by the The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.
  • Skin reaction evaluation
    • Time Frame: At fraction 21 of radiotherapy (week 4) in case of a tumor boost
    • The patients skin reactions will be evaluated by the The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.

Secondary Measures

  • Patient subjective evaluation of skin reactions
    • Time Frame: Baseline
    • The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
  • Patient subjective evaluation of skin reactions
    • Time Frame: Week 1 of radiotherapy
    • The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
  • Patient subjective evaluation of skin reactions
    • Time Frame: Week 2 of radiotherapy
    • The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
  • Patient subjective evaluation of skin reactions
    • Time Frame: At fraction 16 of radiotherapy (week 3)
    • The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
  • Patient subjective evaluation of skin reactions
    • Time Frame: At fraction 21 of radiotherapy (week 4) in case of a tumor boost
    • The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
  • Quality of life assessment
    • Time Frame: Baseline
    • The skindex-29 is a validated instrument to measures patients’ QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
  • Quality of life assessment
    • Time Frame: At fraction 16 of radiotherapy (week 3)
    • The skindex-29 is a validated instrument to measures patients’ QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
  • Quality of life assessment
    • Time Frame: At fraction 21 of radiotherapy (week 4) in case of a tumor boost
    • The skindex-29 is a validated instrument to measures patients’ QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
  • Patients’ satisfaction with the therapeutic intervention
    • Time Frame: At fraction 16 of radiotherapy (week 3)
    • The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).
  • Patients’ satisfaction with the therapeutic intervention
    • Time Frame: At fraction 21 of radiotherapy (week 4) in case of a tumor boost
    • The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jessa Hospital
  • Collaborator
    • Hasselt University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeroen Mebis, MD, PhD, Principal Investigator, Jessa ziekenhuis VZW
  • Overall Contact(s)
    • Jeroen Mebis, MD, PhD, +32 11 33 72 21, Jeroen.mebis@jessazh.be

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