RecruitingNCT05878964

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

420 participants

Start Date

May 22, 2023

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study looks at how cancer immunotherapy drugs (such as anti-PD1/PDL1/CTLA4 agents) and CDK inhibitors affect skin health and quality of life in cancer patients. It is not testing a new treatment — participants are already on approved therapies and complete questionnaires about their skin symptoms. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a solid tumor - You are currently receiving — or about to start — approved immunotherapy or CDK inhibitor treatment - You are able to complete questionnaires **You may NOT be eligible if...** - You are under 18 - You had a skin condition before starting your current cancer treatment - You use chronic steroids - You have a history of psychiatric disorders or are taking antidepressants - You refuse to sign consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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