Clinical trial · Observational
G8, CARG, Frailty, and Nutritional Markers in Predicting Chemotoxicity
Correlation of G8, CARG, and Frailty Scales With Nutritional Biomarkers and G-CSF Requirement in Elderly Cancer Patients: A Prospective Study on Predicting Chemotherapy Toxicity
NCT07151794CI-TRIAL-00094473active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Geriatric Oncology | — | UNRESOLVED | — |
| Nutrition | — | UNRESOLVED | — |
| Nutrition Assessment | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- 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.
Primary outcomes (1)
- measure
- Side effects of chemotherapy
- timeFrame
- From enrollment to 6 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (6)
- BACKGROUNDBellera 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 22250183
- BACKGROUNDChurch 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 33028215
- BACKGROUNDKenis, 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.
- BACKGROUNDDecoster 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 24936581
- BACKGROUNDWildiers, 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.
- BACKGROUNDHurria 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 21810685