Novel Skin Care for Chemotherapy- Related Dermatologic Toxicities

NCT04929847 | Completed

• 1 other identifier: 2021/060
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Skin Toxicity

Keywords

chemotherapy; skin; emollient; oncology

Outcome Measures

Primary Outcomes (4)

• 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: 1. Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective. 2. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective.

  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: 1. Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective. 2. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective.

  Week 3 of chemotherapy (end of study)

Secondary Outcomes (9)

• Patient subjective evaluation of skin reactions

  Baseline

• Patient subjective evaluation of skin reactions

  Week 1 of chemotherapy

• Patient subjective evaluation of skin reactions

  Week 2 of chemotherapy

• Patient subjective evaluation of skin reactions

  Week 3 of chemotherapy (end of study)

• Quality of life - DLQI

  Baseline

Other Outcomes (1)

• General patient-, disease-, and treatment-related information

  Baseline

Study Arms (1)

Group 1

EXPERIMENTAL

All patients will receive the experimental emollient during 3 weeks.

Other: Self-prepared emollient

Interventions

Self-prepared emollient OTHER

The emollient is hypo-allergenic, free of perfume and has very high hydrating capacities together with antioxidants.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with cancer of any type
• Undergoing chemotherapy at the Jessa Hospital (Hasselt, BE)
• Age ≥ 18 years
• Able to comply to the study protocol
• Able to sign written informed consent

You may not qualify if:

• Pre-existing skin rash, ulceration, skin infections or open wounds
• Severe psychological disorder or dementia
• Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Sponsors & Collaborators

• Jessa Hospital: lead
• Hasselt University: collaborator

Study Sites (1)

Jessa Ziekenhuis VZW

Hasselt, Limburg, 3500, Belgium

Location

Related Links

• Manuscript: "Evaluation of a novel skin care product for the management of chemotherapy- related dermatologic toxicities: A quasi-experimental study"

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jeroen Mebis, MD, PhD

  Jessa Ziekenhuis VZW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: October 20, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)