RTSkin: Novel Skin Care Product for the Management of Acute Radiodermatitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Skin reaction evaluation [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 [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 [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 Outcome Measures
- Patient subjective evaluation of skin reactions [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 [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 [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 [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 [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 [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 [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 [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 [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 [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).
Other Outcome Measures
- General patient-, disease-, and treatment-related information [Baseline]
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.
- General patient-, disease-, and treatment-related information [Week 4 of radiotherapy]
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.
- General patient-, disease-, and treatment-related information [Two weeks post-radiotherapy (follow-up)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of breast cancer and underwent lumpectomy or mastectomy
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Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE)
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Age ≥ 18 years
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Able to comply to the study protocol
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Able to sign written informed consent
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Signed written informed consent
Exclusion Criteria:
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Previous irradiation to the breast region
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Metastatic disease
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Patients with pre-existing skin rash, ulceration or open wound in the treatment area
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jessa Ziekenhuis VZW | Hasselt | Limburg | Belgium | 3500 |
Sponsors and Collaborators
- Jessa Hospital
- Hasselt University
Investigators
- Principal Investigator: Jeroen Mebis, MD, PhD, Jessa ziekenhuis VZW
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/058