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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
420 participants
May 22, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- (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 Criteria5
- 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.
Interventions
Quality of life evaluation questionnaire
Quality of life evaluation questionnaire
Self reported evaluation of cutaneous toxicity questionnaire.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05878964