Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.
Recruiting · NCT05878964 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- for all Groups):
- 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.
Where it is running
1 location listed.
- Roberto Iacovelli - Roma, Italy