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Completed

NCT Number: NCT04929847

Novel Skin Care for Chemotherapy- Related Dermatologic Toxicities

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.

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Key information

Conditions

Skin Toxicity Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis VZW

Hasselt, Limburg, 3500, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Self-prepared emollient

Other

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

Primary outcomes

  1. Skin reaction evaluation

    Time frame: Baseline

    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.

  2. Skin reaction evaluation

    Time frame: Week 3 of chemotherapy (End of study)

    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.

  3. Patient benefit composite

    Time frame: Baseline

    The Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components:

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

  4. Patient benefit composite

    Time frame: Week 3 of chemotherapy (end of study)

    The Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components:

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

Secondary outcomes

  1. Patient subjective evaluation of skin reactions

    Time frame: Baseline

    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

  2. Patient subjective evaluation of skin reactions

    Time frame: Week 1 of chemotherapy

    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

  3. Patient subjective evaluation of skin reactions

    Time frame: Week 2 of chemotherapy

    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

  4. Patient subjective evaluation of skin reactions

    Time frame: Week 3 of chemotherapy (end of study)

    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

  5. Quality of life - DLQI

    Time frame: Baseline

    Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.

  6. Quality of life - DLQI

    Time frame: Week 3 of chemotherapy (end of study)

    Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.

  7. Quality of life - Skindex-29

    Time frame: 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).

  8. Quality of life - Skindex-29

    Time frame: Week 3 of chemotherapy (end of study)

    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).

  9. Patients' satisfaction with the therapeutic intervention

    Time frame: Week 3 of chemotherapy (end of study)

    The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products by using a numerical rating scale.

Other outcomes

  1. General patient-, disease-, and treatment-related information

    Time frame: 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 regimen).

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Collaborators

  • Hasselt University

Registry information

Official study title

Evaluation of a Novel Skin Care Product for the Management of Chemotherapy- Related Dermatologic Toxicities

Acronym: ChemoSkin

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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