NCT07184047Befejeződött
Longitudinal Geriatric Vulnerability, Chemotherapy Toxicity, and Functional Outcomes in Older Adults With Gastrointestinal Cancer
Beyond Baseline Frailty Screening: Longitudinal Geriatric Vulnerability, Severe Chemotherapy Toxicity, and Functional Decline in Older Adults With Nonmetastatic Gastrointestinal Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 16.
Rövid összefoglaló (regiszter, angolul)
Older adults with gastrointestinal cancers may be more likely to experience side effects from chemotherapy and difficulties with everyday activities. These problems are not always explained by age alone. Changes in nutrition, physical strength, general health, and independence may also affect how well a person tolerates cancer treatment. The purpose of the VITAL-GI study is to better understand how health-related vulnerability in older adults is associated with chemotherapy side effects and changes in daily functioning over time. This is an observational study involving adults aged 65 years or older with gastrointestinal cancer that has not spread to distant parts of the body. Participants receive chemotherapy as part of their usual medical care, either before or after surgery, according to their treatment plan. The study does not assign chemotherapy treatments or change routine care. Researchers use questionnaires and clinical information to assess general health, nutrition, physical abilities, independence, and the risk of chemotherapy side effects. Assessments are performed when chemotherapy begins and approximately 3 and 6 months later. The study examines whether initial health assessments can help identify people who are more likely to experience serious chemotherapy side effects. It also examines how health, daily activities, symptoms, and quality of life change during treatment. The findings may help researchers better understand the supportive care needs of older adults receiving chemotherapy for gastrointestinal cancer.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 132 (tényleges)
- Első benyújtás
- 2025. szept. 14.
- Kezdés
- 2024. jan. 15.
- Elsődleges befejezés
- 2025. febr. 1.
- Fő szponzor
- Ankara Etlik City Hospital
- NCT-szám
- NCT07184047
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 132
- 2024. jan. 15. és az elsődleges befejezés (2025. febr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- No planned systemic cytotoxic chemotherapy during the study observation period.
- Concurrent participation in an interventional clinical trial that interferes with chemotherapy selection, toxicity assessment, or longitudinal study evaluations.
Más betegség
- Evidence of distant metastatic disease (stage IV) at baseline.
- Severe cognitive impairment or another condition preventing valid baseline geriatric and functional assessment when no protocol-approved assessment assistance is available.
Egyéb
- ECOG performance status ≥3 at study enrollment.
- Inability to provide informed consent according to the approved study procedures.
Kiket keres a vizsgálat
- Age ≥65 years at the time of enrollment.
- Histologically confirmed nonmetastatic or locally advanced gastrointestinal malignancy, including colorectal, pancreatic, gastric, biliary tract, or other protocol-eligible gastrointestinal cancers.
- Clinical stage II or III disease, or locally advanced nonmetastatic disease without a separately specified stage II or III classification.
- Planned initiation of standard-of-care adjuvant or neoadjuvant systemic chemotherapy, including fluoropyrimidine-, oxaliplatin-, irinotecan-, or gemcitabine-based regimens, as clinically appropriate.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at baseline.
- Ability to undergo baseline comprehensive geriatric assessment and participate in scheduled follow-up evaluations at approximately 3 and 6 months after chemotherapy initiation.
- Ability to complete the required geriatric, nutritional, sarcopenia, functional, symptom, and quality-of-life assessments independently or with assistance permitted under the study protocol.
- Provision of written informed consent before study participation.
Életkor a regiszterben: 65 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Etlik City Hospital Medical Oncology Department | Ankara | Törökország | Ismeretlen állapot |
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