CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab

Recruiting

• Conditions: Nivolumab Related Toxicity
• Interventions: Drug: there is no intervention

• Registration Number: NCT05564923
• Lead Sponsor: Namik Kemal University

Brief Summary

The Geriatric 8 (G8), Vulnerable Elders Survey (VES-13), and Cancer and Aging Research Group (CARG) questionnaires are among the main tests whose purpose is to predict the risk of chemotherapy-induced toxicity (CRT) and allow treatment. Investigators aimed to investigate the effect of using the G8, VES13, and CARG scales in the geriatric age group in cancer patients receiving nivolumab treatment in predicting side effects.

Detailed Description

Investigator aimed to examine whether the G8, VES13, and CARG scales can shed light on clinicians in predicting side effects during the use of nivolumab in geriatric cancer patients. In the chemotherapy unit, demographic information, diagnosis date of the disease, previous treatments, comorbidities, and CARG, VES13, and G8 questionnaires will be recorded face-to-face to the patients who meet the study criteria. In addition, routine hemogram and biochemistry tests, which were requested by the patient's follow-up physician before Nivolumab treatment and which will be requested by the patient's own physician during follow-up visits, will be recorded prospectively. Side effects that may occur during nivolumab treatment will be pursued at each visit. CTCA v.6. will be used for grading.

inclusion criteria

1-Advanced cancer patients whose nivolumab treatment was started by the physician followed up (independent of diagnosis) 2-60 years and over, 3-ECOG performance score 0-1 4-Patients who signed the informed consent form

exclusion criteria

1. Under 60 years old

2. Ecog score \>1

Study Timeline

• Study Start: 2022-09-02
• Study First Submitted: 2022-09-02
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-02
• Last Update Submitted: 2022-10-02
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Primary Completion: 2023-06-17
• Study Completion: 2023-08-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Advanced stage cancer patients who have been treated with nivolumab
• be over 60 years old

Exclusion Criteria

• be under the age of 60

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	there is no intervention	Advanced cancer patients over 65 years of age receiving nivolumab

Primary Outcome Measures

Name	Time	Method
grade 3-4 nivolumab toxicity	one year from first patient enrolled	grading will be made according to the CTCA V.6

Trial Locations

Locations (1)

Tekirdağ Namık Kemal University; 🇹🇷 Tekirdağ, Turkey