Novel Skin Care Product for the Management of Acute Radiodermatitis

Radiation Dermatitis Clinical Trial

— RTSkin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929808
• Other study ID #: 2021/058
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: July 2023
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis VZW	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Jessa Hospital	Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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)
Primary	Skin reaction evaluation	The patients skin reactions will be evaluated by the modified version of the RTOG criteria	Baseline
Primary	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 )
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	Pruritus evaluation	The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria	Baseline
Secondary	Pruritus evaluation	The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria	At fraction 15/16 of radiotherapy (week 3)
Secondary	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