Novel Skin Care Product for the Management of Acute Radiodermatitis (RTSkin)

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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Dermatitis; Radiodermatitis; Acute
• Intervention / Treatment: Other: Standard institutional skin care; Other: Hydrating emollient for acute radiodermatitis

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Mebis, MD, PhD; Phone Number: +32 11 33 72 21; Email: Jeroen.mebis@jessazh.be
• Study Contact Backup: Name: Jolien Robijns, PhD; Phone Number: +32 11 33 72 29; Email: jolien.robijns@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis vzw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Will receive the standard institutional skin care for acute radiodermatitis	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.
Experimental: Experimental group; Will receive the novel, self-prepared skin care product	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient subjective evaluation of skin reactions	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	Baseline
Patient subjective evaluation of skin reactions	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	Week 1 of radiotherapy
Patient subjective evaluation of skin reactions	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	Week 2 of radiotherapy
Quality of life assessment	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).	Baseline
Patient subjective evaluation of skin reactions	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	At fraction 15/16 of radiotherapy (week 3)
Patient subjective evaluation of skin reactions	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	At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Quality of life assessment	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).	At fraction 15/16 of radiotherapy (week 3)
Quality of life assessment	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).	At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Patients' satisfaction with the therapeutic intervention	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).	At fraction 15/16 of radiotherapy (week 3)
Patients' satisfaction with the therapeutic intervention	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).	At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Pruritus evaluation	The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria	Baseline
Pruritus evaluation	The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria	At fraction 15/16 of radiotherapy (week 3)
Pruritus evaluation	The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria	At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.	Baseline
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.	Week 4 of radiotherapy
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.	Two weeks post-radiotherapy (follow-up)

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Collaborators: Hasselt University
• Investigators: Principal Investigator: Jeroen Mebis, MD, PhD, Jessa Ziekenhuis vzw

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy; Oncology; Skin care; Skin toxicity; Emollient
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis; Dermatologic Agents; Emollients
• Other Study ID Numbers: 2021/058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No