Actively Recruiting
Correlation of the Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores and Unplanned Hospitalizations in Older Cancer Patients A Multi-center Prospective Cohort Study
Led by RenJi Hospital · Updated on 2025-04-02
322
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of chemotherapy-related toxicity on older cancer patients in China. It focuses on patients aged 70 and above undergoing systemic chemotherapy and investigates whether the Cancer and Aging Research Group (CARG) chemotherapy toxicity risk score can predict treatment-related adverse effects and unplanned hospitalizations. The study addresses the need for better understanding and prevention of chemotherapy risks in the older population with cancer, where organ function decline and treatment tolerance vary. The study is a multi-center prospective cohort involving older adults with solid tumors starting a new chemotherapy regimen at Renji Hospital and Henan Cancer Hospital. Participants will complete the CARG chemotherapy toxicity risk score questionnaire at the start of chemotherapy. Data on demographics, tumor type and stage, clinical status, and treatment details such as chemotherapy regimen, combined therapies, and treatment line will be collected. Outcomes including toxicity, unplanned hospitalizations, and chemotherapy completion will be tracked throughout treatment. Participants will be followed up during and after chemotherapy to assess adverse events and hospitalizations using standardized criteria like CTCAE v4.0. The study will document whether chemotherapy is discontinued, doses are reduced, delayed, or missed, and relative dose intensity changes. Data will be collected until one month after chemotherapy completion or six months after starting treatment. This comprehensive monitoring aims to provide insights into chemotherapy risks and guide care for older cancer patients.
CONDITIONS
Brief Title
Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores in Older Adults With Cancer in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- Confirmed diagnosis of solid tumor of any stage
- ECOG performance status score between 0 and 2
- Admission to hospital for a new chemotherapy regimen (initial or change)
- Ability to read, write, or communicate in Chinese
- Ability to provide informed consent
You will not qualify if you...
- Receiving only immunotherapy and/or targeted therapy without chemotherapy
- Diagnosis of hematologic (blood) malignancy
- Having severe infections such as sepsis or serious respiratory, urinary, or abdominal infections
- Severe heart, liver, or kidney dysfunction or failure
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months from the start of chemotherapy
Participants complete the CARG chemotherapy toxicity risk score questionnaires upon starting a new chemotherapy regimen. Demographics, tumor and clinical characteristics, and treatment details are documented. Toxicity, unplanned hospitalizations, and chemotherapy treatment completion are assessed during planned and unplanned hospital visits.
Visits occur at each planned admission and unplanned hospitalization during chemotherapy and up to 1 month after completion
Trial Site Locations
Total: 2 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
2
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
L
Lirong Yang
X
Xiaoxia Qiu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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