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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how certain cancer treatments affect skin health and quality of life for patients. Specifically, it looks at patients receiving immune checkpoint inhibitors or CDK inhibitors, which are types of medications used to treat various cancers including lung, breast, kidney, bladder, gastric, skin, melanoma, and head and neck cancers. The study will first examine patients who have been on these treatments for at least three months to see how skin issues relate to their overall well-being. Then, it will follow new patients starting these treatments for three months to see how their skin reactions might impact their quality of life.

To participate, individuals must be at least 18 years old, have a confirmed diagnosis of a solid tumor, and be able to complete questionnaires during the study. They also need to provide written consent to join. However, those with existing skin diseases, chronic steroid use, or certain mental health conditions are not eligible. Participants will fill out surveys about their skin health and quality of life, helping researchers understand the connection between skin reactions and overall health during cancer treatment.

Gender

ALL

Eligibility criteria

• 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.