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

October 3, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients affected by solid tumors already in treatment (Phase I) or eligible for treatment (Phase II) with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors at the unit of Medical Oncology of Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome for any type of cancer, and satisfying the related inclusion criteria onwards exposed.

Description

Inclusion Criteria:

(for all Groups)

  1. Age ≥ 18 years.
  2. Histological diagnosis of solid tumor.
  3. Patient able to complete the questionnaires submitted during the study.
  4. 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):

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
All patients affected by solid tumors already in treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.
Other: EQ-5D-5L questionnaire
Quality of life evaluation questionnaire
Other: FACT-G (Functional Assessment of Cancer Therapy - General)
Quality of life evaluation questionnaire
Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)
Self reported evaluation of cutaneous toxicity questionnaire.
Group 2
All patients affected by solid tumors already eligible for treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.
Other: EQ-5D-5L questionnaire
Quality of life evaluation questionnaire
Other: FACT-G (Functional Assessment of Cancer Therapy - General)
Quality of life evaluation questionnaire
Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)
Self reported evaluation of cutaneous toxicity questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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.
18 months
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Roberto Iacovelli, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Estimated)

July 22, 2025

Study Completion (Estimated)

September 22, 2025

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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