NCT05564923

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Namik Kemal University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Nivolumab Related Toxicity

Interventions

Type	Name	Description
DRUG	there is no intervention	there is no intervention

Timeline

• Start date: 2022-09-02
• Primary completion: 2023-06-17
• Completion: 2023-08-17
• First posted: 2022-10-04
• Last updated: 2022-10-04

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study