Evaluating skin health and quality of life in cancer patients on specific therapies
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
This study is trying to see how skin problems from certain cancer treatments affect the daily lives of patients receiving those therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05878964 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the connection between skin-related side effects and the quality of life in patients undergoing treatment with immune checkpoint inhibitors or CDK inhibitors. It will be conducted in two phases: first, assessing patients already receiving these therapies for at least three months, and second, evaluating newly treated patients over a three-month period. The study will utilize validated questionnaires to gather data on skin toxicity and its impact on patients' daily lives.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histological diagnosis of solid tumors currently receiving or eligible for anti-PD1/PDL1/CTLA4 or CDK inhibitors.
Not a fit: Patients under 18, those with pre-existing skin conditions, or those on chronic steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how cancer treatments affect skin health and overall quality of life, leading to improved patient care.
How similar studies have performed: While similar studies have explored the effects of cancer treatments on quality of life, this specific focus on skin toxicity and its relationship to quality of life is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma
- Roberto Iacovelli — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Iacovelli — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Roberto Iacovelli
- Email: roberto.iacovelli@policlinicogemelli.it
- Phone: +390630157373
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.