Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
150 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-12-10
Study Completion Date
2026-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Oncology
Geriatric Oncology
Physiology
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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.
* 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).
* 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).
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Çanakkale Onsekiz Mart University
OTHER
Sponsor Role
lead
Responsible Party
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Cemre Aydeğer
Reseach Asistant, Dr.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Çanakkale Onsekiz Mart Univercity
Çanakkale, , Turkey (Türkiye)
Site Status
Countries
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Turkey (Türkiye)
References
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Runzer-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.
Reference Type
BACKGROUND
Retornaz 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.
Reference Type
BACKGROUND
Ostwal 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.
Reference Type
BACKGROUND
Kenis 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.
Reference Type
BACKGROUND
Juthani 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.
Reference Type
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.
Reference Type
BACKGROUND
Goede V. Frailty and Cancer: Current Perspectives on Assessment and Monitoring. Clin Interv Aging. 2023 Mar 28;18:505-521. doi: 10.2147/CIA.S365494. eCollection 2023.
Reference Type
BACKGROUND
Feliu J, Jimenez-Munarriz B, Basterretxea L, Paredero I, Llabres E, Antonio-Rebollo M, Losada B, Espinosa E, Girones R, Custodio AB, Del Mar Munoz M, Diaz-Almiron M, Gomez-Mediavilla J, Pinto A, Torregrosa MD, Soler G, Cruz P, Higuera O, Molina-Garrido MJ. Predicting Chemotherapy Toxicity in Older Patients with Cancer: A Multicenter Prospective Study. Oncologist. 2020 Oct;25(10):e1516-e1524. doi: 10.1634/theoncologist.2019-0701. Epub 2020 Apr 30.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Chon J, Timilshina N, AlMugbel F, Jin R, Monginot S, Tejero I, Breunis H, Alibhai SMH. Validity of a self-administered G8 screening test for older patients with cancer. J Geriatr Oncol. 2023 Sep;14(7):101553. doi: 10.1016/j.jgo.2023.101553. Epub 2023 Jun 26.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
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COMU-FNO-1
Identifier Type: -
Identifier Source: org_study_id
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