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2021-12-01
2026-07-31
2026-07-31
138
NCT06040801
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
INTERVENTIONAL
Effect of Geriatric Intervention in Frail Patients with Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy
Gastric, biliary and pancreatic cancer are commonly malignancies from gastro- intestinal tract in Taiwan. Because lack of specific symptoms at presentation and effective screening methodology, majority of these patients are diagnosed with metastatic or unresectable disease. Palliative chemotherapy is the good standard of therapy for patients with unresectable gastric, biliary and pancreatic cancer with benefit of prolong survival time and improve quality of life. Although the benefit of palliative chemotherapy seems to be the same for elderly and young cancer patients in clinical study, elderly patients are less frequently treated with chemotherapy or treated with suboptimal dosage. Elderly patients do not receive palliative chemotherapy because concerns of elder age, comorbidity, poor performance, lack of social/economic support and worry about treatment toxicities. The increase in life expectancy of the general population resulted in an increase in the number of elderly patients with cancers referred for palliative chemotherapy. Overtreatment may result in high mortality due to disregard of the aging patients' frailty; on the other hand, under-treatment resulting from over-concern regarding their ability to tolerate treatment, may compromise the survival outcome. Therefore, the appropriately selection of geriatric cancer patients for palliative chemotherapy has to be addressed urgently. Frailty is a progressive decline of physiological reserve leading to multiple functional disability and increases vulnerability to subsequent morbidity and mortality. Frailty is associated with treatment toxicity, chemotherapy tolerance, and survival outcome in clinical oncology. Recent randomized study reported geriatric intervention significantly improved chemotherapy tolerance in elderly patients. Therefore, the American Cancer Association has recommended routine geriatric assessment and intervention in oncogeriatric patients upon providing antitumor treatments. However, the effect of geriatric intervention on chemotherapy tolerance is seldom in Taiwan. This study is an open, randomized, prospective trial to evaluate the effect of geriatric intervention on chemotherapy tolerance in patients with unresectable gastric, biliary, and pancreatic cancer. All patients with receive frailty assessment within 7 days before initiation of first cycle palliative chemotherapy followed by geriatric intervention. The study aim is to compare for chemotherapy tolerance, treatment-related toxicity, and quality of life after completion 3 months chemotherapy treatment course between frail and non-frail patients. This study also aims to explore the effect of geriatric intervention of treatment tolerance, treatment-related toxicity, and quality of life in frail patients with gastric, biliary, and pancreatic cancer receiving palliative chemotherapy.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-08-29 | N/A | 2025-02-11 |
2023-09-10 | N/A | 2025-02-13 |
2023-09-18 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Frail group All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will | BEHAVIORAL: Frailty intervention measures
|
| NO_INTERVENTION: Non-frail group All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Examine the completion rate of chemotherapy in frail and non-frail patient groups three months after treatment initiation to assess whether frailty affects tolerance. | After completion 3 months chemotherapy treatment. | |
| Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-frail patient groups, and compare the differences between the two. | After completion 3 months chemotherapy treatment. | |
| Assess the level of quality of life in frail and non-frail patient groups before and after treatment using EORTC QLQ-C30 v3 and EORTC QLQ-ELD14. | After completion 3 months chemotherapy treatment. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Wen-Chi Chou, M.D. Phone Number: +886328-1200 Email: f12986@cgmh.org.tw |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
65 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
