Clinical trial NCT05878964: Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Breast Cancer
Kidney Cancer
Bladder Cancer
Gastric Cancer
Skin Cancer
Melanoma
Head Neck Cancer
Keywords: immunotherapy
cyclin-dependent kinase (CDK) inhibitors
cutaneous toxicity
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients affected by solid tumors already in treatment (Phase I) or eligible for treatment (Phase II) with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors at the unit of Medical Oncology of Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome for any type of cancer, and satisfying the related inclusion criteria onwards exposed.

Brief 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 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.

Primary outcomes:
measure: Quality of life in patients undergoing anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors evaluated by EQ-5D-5L questionnaire.
timeFrame: 18 months
measure: Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors by FACT-G scale
timeFrame: 18 months
measure: Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors by FACT-EGFRI-18 scale. For all FACIT measures, higher scores are better than lower scores.
timeFrame: 18 months
Secondary outcomes:
measure: Role of gender
timeFrame: 18 months
measure: Role of therapy
timeFrame: 18 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Roberto Iacovelli
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Roberto Iacovelli
role: PRINCIPAL_INVESTIGATOR
References: