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

NCT05878964 | Recruiting

• 1 other identifier: 5455
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Breast Cancer; Kidney Cancer; Bladder Cancer; Gastric Cancer; Skin Cancer; Melanoma; Head Neck Cancer

Keywords

immunotherapy; cyclin-dependent kinase (CDK) inhibitors; cutaneous toxicity

Outcome Measures

Primary Outcomes (3)

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

  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

  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.

  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 Outcomes (2)

• Role of gender

  18 months

• Role of therapy

  18 months

Study Arms (2)

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; Other: FACT-G (Functional Assessment of Cancer Therapy - General); Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)

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; Other: FACT-G (Functional Assessment of Cancer Therapy - General); Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)

Interventions

EQ-5D-5L questionnaire OTHER

Quality of life evaluation questionnaire

Group 1; Group 2

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

Quality of life evaluation questionnaire

Group 1; Group 2

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

Self reported evaluation of cutaneous toxicity questionnaire.

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Roberto Iacovelli

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms; Stomach Neoplasms; Skin Neoplasms; Melanoma; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Roberto Iacovelli

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Iacovelli

CONTACT

+390630157373; roberto.iacovelli@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 30, 2023
• Study Start: May 22, 2023
• Primary Completion: July 22, 2025
• Study Completion: September 22, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)