Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055387
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-08-29
Brief Title:
Frailty Assessment and Intervention in Elderly Patients With Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Frailty Assessment and Intervention in Elderly Patients With Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric cancer ranks among the top ten leading causes of death in Taiwan Radical surgery is the sole curative method for gastric cancer However our previous research has revealed that elderly gastric cancer patients undergoing radical surgery face a significantly elevated risk of postoperative complications Even after gastric cancer resection only 70 of patients receive adjuvant chemotherapy with a particularly low likelihood among those aged 65 to undergo such treatment With the increasing elderly population in our country an increasing number of elderly gastric cancer patients must decide whether they can withstand radical surgery for gastric cancer and whether to undergo adjuvant chemotherapy Therefore increasing the rates of elderly gastric cancer patients undergoing radical surgery and adjuvant chemotherapy as well as improving the success rate of chemotherapy has become a critical issue
Frailty has been a frequent topic in geriatric medicine in recent years It involves assessing multifaceted aspects of physical functioning to determine an individuals frailty status which can help predict the likelihood of severe side effects from medical interventions International organizations like the American Cancer Society recommend frailty assessment for all elderly cancer patients before undergoing chemotherapy and corresponding interventions to address frailty However there is a lack of large-scale studies on frailty assessment and its practical clinical benefits in our population
This study is a prospective open-label randomized clinical trial designed to investigate the impact of geriatric intervention on the tolerance of surgerychemotherapy in patients diagnosed with gastric cancer As part of the study protocol all enrolled patients will undergo a comprehensive frailty assessment within a window of 7 days before initiating their first treatment followed by tailored geriatric interventions
The primary objective of this study is to assess and compare the effects of geriatric intervention on postoperative complications chemotherapy tolerance treatment-related toxicity and overall quality of life among two distinct groups frail and non-frail patients Our research team aims to promote widespread frailty assessment and interventions with the following objectives
1 Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery
2 Enhance the tolerance and success rate of adjuvant chemotherapy for gastric cancer
These efforts ultimately aim to improve the survival prognosis of this patient group
Frailty has been a frequent topic in geriatric medicine in recent years It involves assessing multifaceted aspects of physical functioning to determine an individuals frailty status which can help predict the likelihood of severe side effects from medical interventions International organizations like the American Cancer Society recommend frailty assessment for all elderly cancer patients before undergoing chemotherapy and corresponding interventions to address frailty However there is a lack of large-scale studies on frailty assessment and its practical clinical benefits in our population
This study is a prospective open-label randomized clinical trial designed to investigate the impact of geriatric intervention on the tolerance of surgerychemotherapy in patients diagnosed with gastric cancer As part of the study protocol all enrolled patients will undergo a comprehensive frailty assessment within a window of 7 days before initiating their first treatment followed by tailored geriatric interventions
The primary objective of this study is to assess and compare the effects of geriatric intervention on postoperative complications chemotherapy tolerance treatment-related toxicity and overall quality of life among two distinct groups frail and non-frail patients Our research team aims to promote widespread frailty assessment and interventions with the following objectives
1 Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery
2 Enhance the tolerance and success rate of adjuvant chemotherapy for gastric cancer
These efforts ultimately aim to improve the survival prognosis of this patient group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None