Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Lung Cancer, Breast Cancer, Kidney Cancer, Bladder Cancer, Gastric Cancer, Skin Cancer

Being tested

EQ-5D-5L questionnaire, FACT-G (Functional Assessment of Cancer Therapy - General), FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)

Keywords

immunotherapy, cyclin-dependent kinase (CDK) inhibitors, cutaneous toxicity

Medical subject headings

Lung Neoplasms, Breast Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms, Stomach Neoplasms, Skin Neoplasms, Melanoma, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• EQ-5D-5L questionnaireOther

  Quality of life evaluation questionnaire

• FACT-G (Functional Assessment of Cancer Therapy - General)Other

  Quality of life evaluation questionnaire

• FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)Other

  Self reported evaluation of cutaneous toxicity questionnaire.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Quality of life in patients undergoing anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors evaluated by EQ-5D-5L questionnaire.

   To evaluate the correlation between skin toxicity and quality of life over three months of treatment in patients initially naïve for monoclonal antibody anti-PD1/PDL1/CTLA4 or with cyclin-dependent kinase (CDK) inhibitors.

   Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0.

   The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

   The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

   The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

   Measured: 18 months

2. Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors by FACT-G scale

   To evaluate the correlation between skin toxicity and quality of life over three months of treatment in patients initially naïve for monoclonal antibody anti-PD1/PDL1/CTLA4 or with cyclin-dependent kinase (CDK) inhibitors.

   Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0.

   The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. For all FACIT measures, higher scores are better than lower scores.

   Measured: 18 months

3. 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.

   To evaluate the correlation between skin toxicity and quality of life over three months of treatment in patients initially naïve for monoclonal antibody anti-PD1/PDL1/CTLA4 or with cyclin-dependent kinase (CDK) inhibitors.

   Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0.

   Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted30 May 2023
2. Study start22 May 2023
3. Primary completion22 Jul 2025 (estimated)
4. Study completion22 Sep 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Lung CancerStudies of the same condition, open and under way.
• More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.