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| Name | Class |
|---|---|
| Hasselt University | OTHER |
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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 chemotherapeutic agents. The chemotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival.
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 ChemoSkin project, a novel emollient to tackle the cutaneous adverse events of chemotherapy has been developed.
The ChemoSkin project general aim is to evaluate the efficacy of a novel skincare product to manage chemotherapy-related cutaneous toxicities.
Primary objective Evaluate the efficacy of a novel emollient for the management of chemotherapy-related cutaneous adverse events
Secondary objective 1 Evaluate patient-relevant treatment benefit of the novel emollient for chemotherapy-associated cutaneous toxicities
Secondary objective 2 Evaluate the influence of the novel emollient for chemotherapy- associated cutaneous toxicities on the patient's quality of life
Secondary objective 3 Evaluate the safety of the novel emollient for chemotherapy- associated cutaneous toxicities
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | All patients will receive the experimental emollient during 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-prepared emollient | Other | The emollient is hypo-allergenic, free of perfume and has very high hydrating capacities together with antioxidants. |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin reaction evaluation | The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5. | Baseline |
| Skin reaction evaluation | The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5. | Week 3 of chemotherapy (End of study) |
| Patient benefit composite | The Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components:
| Baseline |
| Patient benefit composite | The Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components:
| Week 3 of chemotherapy (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity 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 |
| 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 regimen). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Mebis, MD, PhD | Jessa Ziekenhuis VZW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis VZW | Hasselt | Limburg | 3500 | Belgium |
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| Label | URL |
|---|---|
| Manuscript: "Evaluation of a novel skin care product for the management of chemotherapy- related dermatologic toxicities: A quasi-experimental study" | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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The patients will be asked to complete a questionnaire to evaluate the intensity of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale |
| Week 1 of chemotherapy |
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Week 2 of chemotherapy |
| Patient subjective evaluation of skin reactions | The patients will be asked to complete a questionnaire to evaluate the intensity of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale | Week 3 of chemotherapy (end of study) |
| Quality of life - DLQI | Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients. | Baseline |
| Quality of life - DLQI | Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients. | Week 3 of chemotherapy (end of study) |
| Quality of life - Skindex-29 | 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 |
| Quality of life - Skindex-29 | 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). | Week 3 of chemotherapy (end of study) |
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products by using a numerical rating scale. | Week 3 of chemotherapy (end of study) |
| Baseline |