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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-22

Study Completion Date

2025-09-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer Breast Cancer Kidney Cancer Bladder Cancer Gastric Cancer Skin Cancer Melanoma Head Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

All patients affected by solid tumors already in treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.

EQ-5D-5L questionnaire

Intervention Type OTHER

Quality of life evaluation questionnaire

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

Intervention Type OTHER

Quality of life evaluation questionnaire

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

Intervention Type OTHER

Self reported evaluation of cutaneous toxicity questionnaire.

Group 2

All patients affected by solid tumors already eligible for treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.

EQ-5D-5L questionnaire

Intervention Type OTHER

Quality of life evaluation questionnaire

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

Intervention Type OTHER

Quality of life evaluation questionnaire

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

Intervention Type OTHER

Self reported evaluation of cutaneous toxicity questionnaire.

Interventions

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EQ-5D-5L questionnaire

Quality of life evaluation questionnaire

Intervention Type OTHER

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

Quality of life evaluation questionnaire

Intervention Type OTHER

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

Self reported evaluation of cutaneous toxicity questionnaire.

Intervention Type OTHER

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No