NCT05878964

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 420 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-22
• Primary completion: 2025-07-22
• Completion: 2025-09-22
• First posted: 2023-05-30
• Last updated: 2024-10-04

Locations

1 site across 1 country: Italy