Clinical trial · Observational
Predicting Chemo Toxicity Using Geriatric Forms
Correlation and Comparison Analyses of CARG, G8, and Frailty Tests in Predicting Chemotherapy-Associated Toxicity: A Prospective Study
- 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 prospective observational study aims to evaluate and compare the effectiveness of three geriatric assessment tools-CARG (Cancer and Aging Research Group score), G8 screening tool, and Frailty Scale-in predicting chemotherapy-related toxicity (CRT) in cancer patients aged 65 years and older. A total of at least 100 patients receiving standard chemotherapy (excluding hematologic malignancies and immunotherapy) at Çanakkale University Medical Faculty Oncology Clinic will be assessed prior to treatment initiation. Each participant will undergo baseline evaluations including G8, CARG, and Frailty assessments. The study will analyze the correlation between these tools and the occurrence of CRT using AUC, logistic regression, and correlation analyses. The goal is to identify the most accurate and practical screening tool to guide clinical decision-making and minimize chemotherapy toxicity in older adults.
Conditions
Conditions (3)
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 | — |
| Oncology | — | UNRESOLVED | — |
| Physiology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Geriartric Form Results and Chemotherapy Side Effects
- timeFrame
- From enrollment to 6 month
- description
- ARG (Cancer and Aging Research Group score)
- measure
- G8 screening tool
- timeFrame
- From enrollment to 6 month
- description
- prediction side effets on chemotherapy on patient
- measure
- Frailty Scale
- timeFrame
- From enrollment to 6 month
- description
- Predicting side effect chemoterapy in elderly patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 65 years or older. * Histologically confirmed cancer diagnosis with a pre-planned chemotherapy regimen (adjuvant, neoadjuvant, or palliative intent). * Chemotherapy not yet initiated at the time of enrollment. * Clinically stable condition, as assessed by the oncologist. * Willingness and ability to provide written informed consent. Exclusion Criteria: * Presence of acute infection or advanced organ failure (cardiac, hepatic, or renal). * Severe psychiatric illness or cognitive impairment that interferes with the ability to complete assessments. * Patients receiving concurrent hormonal therapy, targeted therapy, immunotherapy, or radiotherapy. * Diagnosis of hematologic malignancies (e.g., leukemia, lymphoma, myeloma).
References
Publications (12)
- BACKGROUNDRunzer-Colmenares FM, Urrunaga-Pastor D, Roca-Moscoso MA, De Noriega J, Rosas-Carrasco O, Parodi JF. Frailty and Vulnerability as Predictors of Chemotherapy Toxicity in Older Adults: A Longitudinal Study in Peru. J Nutr Health Aging. 2020;24(9):966-972. doi: 10.1007/s12603-020-1404-6. PMID 33155622
- BACKGROUNDRetornaz F, Guillem O, Rousseau F, Morvan F, Rinaldi Y, Nahon S, Castagna C, Boulahssass R, Grino M, Gholam D. Predicting Chemotherapy Toxicity and Death in Older Adults with Colon Cancer: Results of MOST Study. Oncologist. 2020 Jan;25(1):e85-e93. doi: 10.1634/theoncologist.2019-0241. Epub 2019 Aug 6. PMID 31387952
- BACKGROUNDOstwal V, Ramaswamy A, Bhargava P, Hatkhambkar T, Swami R, Rastogi S, Mandavkar S, Ghosh J, Bajpai J, Gulia S, Srinivas S, Rath S, Gupta S. Cancer Aging Research Group (CARG) score in older adults undergoing curative intent chemotherapy: a prospective cohort study. BMJ Open. 2021 Jun 29;11(6):e047376. doi: 10.1136/bmjopen-2020-047376. PMID 34187825
- BACKGROUNDKenis C, Bron D, Libert Y, Decoster L, Van Puyvelde K, Scalliet P, Cornette P, Pepersack T, Luce S, Langenaeken C, Rasschaert M, Allepaerts S, Van Rijswijk R, Milisen K, Flamaing J, Lobelle JP, Wildiers H. Relevance of a systematic geriatric screening and assessment in older patients with cancer: results of a prospective multicentric study. Ann Oncol. 2013 May;24(5):1306-12. doi: 10.1093/annonc/mds619. Epub 2013 Jan 4. PMID 23293115
- BACKGROUNDJuthani R, Punatar S, Mittra I. New light on chemotherapy toxicity and its prevention. BJC Rep. 2024 May 22;2(1):41. doi: 10.1038/s44276-024-00064-8. PMID 39516565
- 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.