G8, VES-13 and CARG Scores in Predicting Chemotherapy Toxicity in Geriatric Cancer Patients

August 1, 2021 updated by: Asoc. Prof. Erdoğan Selçuk Şeber, Namik Kemal University

The Predictive Value of G8, VES-13 and CARG Scores in Treatment-related Toxicity in Geriatric Cancer Patients

All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. The suitability of G8, VES-13 and CARG chemotherapy risk assessment tools for elderly cancer patients was investigated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. G8, VES-13 and CARG toxicity scores of all participating patients will be determined by two independent investigators before starting chemotherapy. The suitability of these practical chemotherapy risk assessment tools for cancer patients for elderly cancer patients was investigated.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tekirdağ, Turkey
        • Tekirdag Namık Kemal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Older Patients Receiving Chemotherapy

Description

Inclusion Criteria:

  • Aged ≥65 years
  • Localized or metastatic solid carcinoma diagnosed by histology (any type, any stage)
  • Starting a new-line (first-line, second-line or third-line) chemotherapy

Exclusion Criteria:

  • Concurrent radiotherapy;
  • Simultaneous immunotherapy
  • Impaired language
  • Cognitive function leading to inability to complete assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
G8 (Geriatric 8) screening tool measurement
Time Frame: 15-30 minutes
15-30 minutes
CARG (Cancer and Aging Research Group) chemotherapy toxicity score measurement
Time Frame: 30-60 minutes
30-60 minutes
VES-13 (Vulnerable Elders Survey-13) measurement
Time Frame: 30-60 minutes
30-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Investigators

  • Study Chair: Erdoğan S Şeber, Assoc. Prof., Tekirdag Namık Kemal University
  • Study Director: Eyyüp Çavdar, MD, Tekirdag Namık Kemal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

August 1, 2021

First Posted (ACTUAL)

August 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHEMOTOXTOOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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