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NCT Number: NCT05878964

Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.

The study aim to investigate the relationship between cutaneous adverse events and quality of life in patients taking immune check point inhibitor or cyclin-dependent kinase (CDK) 4 and 6 inhibitors by two steps. In the first one, it will be investigated the relationship between the skin toxicity related to the use selected therapies and the quality of life of patients already receiving these therapies for treatment of their cancer. In the second one, it will be evaluated the relationship between skin toxicity and quality of life over three months of treatment in patients initially naïve for selected therapies. Cancer included in the analysis are NSCLC, renal cancer, gastric cancer, breast cancer, bladder cancer, melanoma, squamous cell carcinoma of the head and neck.

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Key information

Conditions

Lung Cancer Bladder Cancer Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head Neck Cancer Head and Neck Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Roberto Iacovelli

Roma, 00168, Italy

Location status: Recruiting

Location contact

Roberto Iacovelli

PRINCIPAL_INVESTIGATOR

Roberto Iacovelli, Prof

CONTACT

[email protected]

+390630157373

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(for all Groups)

  • Age ≥ 18 years.
  • Histological diagnosis of solid tumor.
  • Patient able to complete the questionnaires submitted during the study.
  • Signed written informed consent. (for Group I) Patients already under treatment for at least three months with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.

(for Group II) Patients eligible for treatment with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.

Exclusion criteria

(for all Groups):

  • Age < 18 y.o.
  • Skin diseases or alterations present before the beginning of anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.
  • Chronic use of steroids.
  • Previous psychiatric disorders or patients taking antidepressant.
  • Refusal to sign written informed consent.

Treatment and study plan

EQ-5D-5L questionnaire

Other

Quality of life evaluation questionnaire

FACT-G (Functional Assessment of Cancer Therapy - General)

Other

Quality of life evaluation questionnaire

FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)

Other

Self reported evaluation of cutaneous toxicity questionnaire.

Primary outcomes

  1. Quality of life in patients undergoing anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors evaluated by EQ-5D-5L questionnaire.

    Time frame: 18 months

    To evaluate the correlation between skin toxicity and quality of life over three months of treatment in patients initially naïve for monoclonal antibody anti-PD1/PDL1/CTLA4 or with cyclin-dependent kinase (CDK) inhibitors.

    Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0.

    The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

  2. Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors by FACT-G scale

    Time frame: 18 months

    To evaluate the correlation between skin toxicity and quality of life over three months of treatment in patients initially naïve for monoclonal antibody anti-PD1/PDL1/CTLA4 or with cyclin-dependent kinase (CDK) inhibitors.

    Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0.

    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. For all FACIT measures, higher scores are better than lower scores.

  3. Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors by FACT-EGFRI-18 scale. For all FACIT measures, higher scores are better than lower scores.

    Time frame: 18 months

    To evaluate the correlation between skin toxicity and quality of life over three months of treatment in patients initially naïve for monoclonal antibody anti-PD1/PDL1/CTLA4 or with cyclin-dependent kinase (CDK) inhibitors.

    Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0.

Secondary outcomes

  1. Role of gender

    Time frame: 18 months

    To describe differences in quality of life based on gender. The incidence and grade of skin toxicity based ob CTCAE v 5.0, will be estimated based on sex. Similarly the correlation of skin toxicity with quality of life evaluated by EQ-5D-5L, FACT-G, FACT-EGFRI-18 measures will be estimated by sex.

  2. Role of therapy

    Time frame: 18 months

    To describe differences in quality of life based on type of therapy received (Immunotherapy vs CDK inhibitors).

    The incidence and grade of skin toxicity based ob CTCAE v 5.0, will be estimated based on type of therapy. Similarly the correlation of skin toxicity with quality of life evaluated by EQ-5D-5L, FACT-G, FACT-EGFRI-18 measures will be estimated by type of therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Iacovelli

CONTACT

[email protected]

+390630157373

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evaluation of Skin Health and Quality of Life in Patients Receiving Anticancer Therapies Based on Monoclonal Antibody Anti-PD1/PDL1/CTLA4 or Cyclin-dependent Kinase (CDK) Inhibitors

Acronym: SkinHealth

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 30, 2023
Registry last updated
Oct 4, 2024

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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