Clinical trial NCT04929808: Novel Skin Care Product for the Management of Acute Radiodermatitis
Official title: Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiodermatitis; Acute
Radiation Dermatitis
Keywords: Skin toxicity
Radiotherapy
Oncology
Skin care
Emollient
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Hasselt University
First posted: 2021-06-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Skin reaction evaluation
timeFrame: Baseline
measure: Skin reaction evaluation
timeFrame: At fraction 15-16 of radiotherapy (week 3 )
measure: Skin reaction evaluation
timeFrame: At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost
Secondary outcomes:
measure: Patient subjective evaluation of skin reactions
timeFrame: Baseline
measure: Patient subjective evaluation of skin reactions
timeFrame: Week 1 of radiotherapy
measure: Patient subjective evaluation of skin reactions
timeFrame: Week 2 of radiotherapy
measure: Patient subjective evaluation of skin reactions
timeFrame: At fraction 15/16 of radiotherapy (week 3)
measure: Patient subjective evaluation of skin reactions
timeFrame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
measure: Quality of life assessment
timeFrame: Baseline
measure: Quality of life assessment
timeFrame: At fraction 15/16 of radiotherapy (week 3)
measure: Quality of life assessment
timeFrame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: At fraction 15/16 of radiotherapy (week 3)
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
measure: Pruritus evaluation
timeFrame: Baseline
measure: Pruritus evaluation
timeFrame: At fraction 15/16 of radiotherapy (week 3)
measure: Pruritus evaluation
timeFrame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Other outcomes:
measure: General patient-, disease-, and treatment-related information
timeFrame: Baseline
measure: General patient-, disease-, and treatment-related information
timeFrame: Week 4 of radiotherapy
measure: General patient-, disease-, and treatment-related information
timeFrame: Two weeks post-radiotherapy (follow-up)
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis VZW
state: Limburg
Study officials:
affiliation: Jessa ziekenhuis VZW
name: Jeroen Mebis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: