Novel Skin Care Product for the Management of Acute Radiodermatitis
- Conditions
- Radiation DermatitisRadiodermatitis; Acute
- Interventions
- Other: Hydrating emollient for acute radiodermatitisOther: Standard institutional skin care
- Registration Number
- NCT04929808
- Lead Sponsor
- Jessa Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Hydrating emollient for acute radiodermatitis Will receive the novel, self-prepared skin care product Control group Standard institutional skin care Will receive the standard institutional skin care for acute radiodermatitis
- Primary Outcome Measures
Name Time Method Skin reaction evaluation At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost The patients skin reactions will be evaluated by the modified version of the RTOG criteria
- Secondary Outcome Measures
Name Time Method Patient subjective evaluation of skin reactions At fraction 20/21 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 At fraction 20/21 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 At fraction 20/21 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).
Pruritus evaluation At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria
Trial Locations
- Locations (1)
Jessa Ziekenhuis VZW
🇧🇪Hasselt, Limburg, Belgium