NCT07151794

Brief Summary

This study aims to evaluate the ability of G8, CARG, and Frailty scales to predict chemotherapy-related toxicity and the need for G-CSF in elderly cancer patients. It also investigates their correlation with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP) and the Mini Nutritional Assessment (MNA) test.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 3, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

July 31, 2025

Last Update Submit

September 1, 2025

Conditions

Geriatric OncologyOncologyNutritionNutrition Assessment

Keywords

G-CSFCARGFrailtyMini Nutritional Assessment (MNA)

Outcome Measures

Primary Outcomes (1)

  • Side effects of chemotherapy

    From enrollment to 6 month

Study Arms (1)

1

The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded.

You may qualify if:

  • Age ≥ 65 years
  • Diagnosed with solid tumor malignancy
  • Planned to undergo at least two cycles of adjuvant, neoadjuvant, or metastatic chemotherapy
  • Clinically stable condition
  • Provided written informed consent

You may not qualify if:

  • Presence of hematological malignancies
  • Concurrent hormonal therapy, targeted therapy, immunotherapy, or radiotherapy
  • Acute infection or advanced organ failure (cardiac, hepatic, renal)
  • Cognitive or psychiatric impairment preventing test participation
  • Prior treatment with G-CSF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakkale Onsekiz Mart Univercity

Çanakkale, 17020, Turkey (Türkiye)

Location

Related Publications (6)

  • Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.

    PMID: 22250183BACKGROUND

  • Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.

    PMID: 33028215BACKGROUND

  • Kenis, C., Bron, D., Libert, Y., et al., Relevance of a geriatric assessment in older patients with cancer: a systematic review, Journal of Geriatric Oncology, 2014, 5(2): 3-9.

    BACKGROUND

  • Decoster L, Van Puyvelde K, Mohile S, Wedding U, Basso U, Colloca G, Rostoft S, Overcash J, Wildiers H, Steer C, Kimmick G, Kanesvaran R, Luciani A, Terret C, Hurria A, Kenis C, Audisio R, Extermann M. Screening tools for multidimensional health problems warranting a geriatric assessment in older cancer patients: an update on SIOG recommendationsdagger. Ann Oncol. 2015 Feb;26(2):288-300. doi: 10.1093/annonc/mdu210. Epub 2014 Jun 16.

    PMID: 24936581BACKGROUND

  • Wildiers, H., Heeren, P., Puts, M., et al., Comprehensive geriatric assessment (CGA) in older patients with cancer: facts and future, The Lancet Oncology, 2014, 15(5): e184-e192.

    BACKGROUND

  • Hurria A, Togawa K, Mohile SG, Owusu C, Klepin HD, Gross CP, Lichtman SM, Gajra A, Bhatia S, Katheria V, Klapper S, Hansen K, Ramani R, Lachs M, Wong FL, Tew WP. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011 Sep 1;29(25):3457-65. doi: 10.1200/JCO.2011.34.7625. Epub 2011 Aug 1.

    PMID: 21810685BACKGROUND

MeSH Terms

Conditions

NeoplasmsFrailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research asistant

Study Record Dates

First Submitted

July 31, 2025

First Posted

September 3, 2025

Study Start

January 2, 2025

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

September 3, 2025

Record last verified: 2025-01

Locations

TU(1)