Clinical trial NCT06717178: Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores in Older Adults With Cancer in China
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Cancer-related Problem/Condition
Keywords: Cancer
Toxicity
Geriatric
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 322
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Academic medical centers

Brief summary: The goal of this observational study is to learn about the impact of chemotherapy-related toxicity on older cancer patients in China. The main question it aims to answer is:

Does the Cancer and Aging Research Group (CARG) chemotherapy toxicity risk score predict chemotherapy-related toxicity in Chinese cancer patients over age 70? Participants over age 70 on systemic chemotherapy will answer questions listed in the CARG chemotherapy toxicity risk tool.

Detailed description: Study Background:

There's a high burden of cancer in the geriatric population. Because of factors such as declining organ function, older adults with cancer generally have lower tolerability of chemotherapy than younger patients. In cancer patients aged ≥ 70 years, chemotherapy-related toxic effects were associated with reduced quality of life and/or decreased physical functioning or death after 1 year. Identifying of older patients at high risk of experiencing chemotherapy-related adverse events is one of the key components for developing new prevention and intervention strategies to improve treatment outcomes in older adults with cancer. The CARG toxicity score prediction model and calculator established by the Cancer and Aging Research Group (CARG) in 2011 is widely used in many countries and regions around the world and are recommended by several international guidelines. However, data from older adults with cancer in China are scarce. Prospective studies exploring the correlation between the CARG chemotherapy risk score and unplanned hospitalizations are limited.

Study Objectives:

* To assess the predictive value of the CARG chemotherapy toxicity risk score in older adults with cancer in China
* To explore the correlation between the CARG scores and the unplanned hospitalizations

Study Method:

This is a multi-center prospective cohort study to collect data from cancer patients aged ≥ 70 years from Renji Hospital and Henan Cancer Hospital. Patients will complete the CARG chemotherapy toxicity risk score questionnaires upon initiating a new chemotherapy regimen. The demographics, tumor characteristics (type of cancer and stage), clinical characteristics (e.g. ECOG performance status, NRS-2002 score, and comorbidities), and cancer treatment (e.g. chemotherapy regimen, line of treatment, combined targeted and/or immunotherapy) will be documented for the baseline evaluation. Toxicity, unplanned hospitalization events, and completion of chemotherapy treatment will be assessed for each visit.

Eligibility criteria: Inclusion Criteria:

* Age≥ 70 years old
* Confirmed diagnosis of solid tumor (any stage)
* ECOG-PS score 0-2 points
* Admission to the hospital for a new chemotherapy regimen (initial or change)
* Patients need to have the ability to read and write, or communicate in Chinese
* The patient must have the ability to give informed consent.

Exclusion Criteria:

* Patients who are on immunotherapy and/or targeted therapy only
* Patients with hematologic malignancy
* Patients with severe infections (sepsis, severe respiratory tract infections, severe urinary tract infections, severe abdominal infections, etc.).
* Patients with severe heart, liver, and kidney dysfunction or failure

Primary outcomes:
measure: Number of Participants with Grade 3-5 Chemotherapy-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
measure: Number of Participants with Unplanned Hospitalization Events
timeFrame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Secondary outcomes:
measure: Number of Participants with Treatment Discontinuation Events
timeFrame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
measure: Number of Participants with Dose Reduction Events
timeFrame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
measure: Number of Participants with Dose Delay Events
timeFrame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
measure: Number of Participants with Dose Missing Events
timeFrame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
measure: Number of Participants with Events of Reduction in Relative Dose Intensity (RDI)
timeFrame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine
name: Lirong Yang, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine
name: Xiaoxia Qiu, MS
role: PRINCIPAL_INVESTIGATOR
References: