To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.
NCT ID:
NCT05878964
Condition:
Lung Cancer
Breast Cancer
Kidney Cancer
Bladder Cancer
Gastric Cancer
Skin Cancer
Melanoma
Head Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Kidney Neoplasms
Mitogens
Conditions: Keywords:
immunotherapy
cyclin-dependent kinase (CDK) inhibitors
cutaneous toxicity
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
EQ-5D-5L questionnaire
Description:
Quality of life evaluation questionnaire
Arm group label:
Group 1
Arm group label:
Group 2
Intervention type:
Other
Intervention name:
FACT-G (Functional Assessment of Cancer Therapy - General)
Description:
Quality of life evaluation questionnaire
Arm group label:
Group 1
Arm group label:
Group 2
Intervention type:
Other
Intervention name:
FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)
Description:
Self reported evaluation of cutaneous toxicity questionnaire.
Arm group label:
Group 1
Arm group label:
Group 2
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roberto Iacovelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberto Iacovelli, Prof
Phone:
+390630157373
Email:
roberto.iacovelli@policlinicogemelli.it
Investigator:
Last name:
Roberto Iacovelli
Email:
Principal Investigator
Start date:
May 22, 2023
Completion date:
September 22, 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05878964
