Frailty Assessment and Intervention in Elderly Patients With Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06055387

Collaborator

Ministry of Health and Welfare, Taiwan (Other)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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 individual's 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 surgery/chemotherapy 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:

Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery.
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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Behavioral: Frailty intervention measures	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Frailty Assessment and Intervention in Elderly Patients With Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Frail group All patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will receive management and recommendations based on the specific impairment domain.	Behavioral: Frailty intervention measures Providing specialized guidance: Physical Function and Fall History: Prioritizing home safety for those with physical impairments. Arranging rehab consultations when necessary. Nutrition: Assessing diets and offering education. Pre-treatment nutritionist assessments. Monitoring weight, intervening if >5-10% loss, or >10% loss. Social Support: Evaluating the needs of those without family support. Referring to social services and introducing care resources. Cognition: Detecting cognitive issues, addressing reversible causes. Assessing decision-making and medication self-administration. Refer to specialists when needed. Polypharmacy and Comorbidity: Collecting medication data, ensuring adherence. Noting chronic illnesses. Collaborating with specialists or pharmacists for complex cases. Psychological: Providing weekly support for psychological concerns. Refer to specialists for assessments and treatment options.
No Intervention: Non-frail group All patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group will not receive additional interventions, but the clinical physicians will still provide appropriate treatment based on the patient's condition.

Arm

Intervention/Treatment

Experimental: Frail group

All patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will receive management and recommendations based on the specific impairment domain.

Behavioral: Frailty intervention measures

Providing specialized guidance: Physical Function and Fall History: Prioritizing home safety for those with physical impairments. Arranging rehab consultations when necessary. Nutrition: Assessing diets and offering education. Pre-treatment nutritionist assessments. Monitoring weight, intervening if >5-10% loss, or >10% loss. Social Support: Evaluating the needs of those without family support. Referring to social services and introducing care resources. Cognition: Detecting cognitive issues, addressing reversible causes. Assessing decision-making and medication self-administration. Refer to specialists when needed. Polypharmacy and Comorbidity: Collecting medication data, ensuring adherence. Noting chronic illnesses. Collaborating with specialists or pharmacists for complex cases. Psychological: Providing weekly support for psychological concerns. Refer to specialists for assessments and treatment options.

No Intervention: Non-frail group

All patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group will not receive additional interventions, but the clinical physicians will still provide appropriate treatment based on the patient's condition.

Outcome Measures

Primary Outcome Measures

Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system. [After completion 3 months 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 treatment.]

Secondary Outcome Measures

Examine whether implementing appropriate frailty interventions can reduce the likelihood of adverse events, as assessed by the Clavien-Dindo grading system or CTCAE v5.0, occurring in frail groups three months after initiating treatment. [After completion 6 months treatment.]
The frail group will receive management and recommendations based on the specific impairment domain.
To compare overall survival between two distinct groups: frail and non-frail patients. [up to 1 year.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged sixty-five or older with locally advanced (stage II and stage III) gastric cancer, preparing for curative gastric cancer surgery and scheduled to receive adjuvant chemotherapy within 4-8 weeks postoperatively, either as outpatients or inpatients.
Patients must provide signed informed consent.
Estimated survival of more than 3 months.
Conscious and able to communicate verbally or in writing, and willing to cooperate with invasive procedures.

Exclusion Criteria:

Patients with cognitive impairment or unable to cooperate with the interventional procedures as determined by the clinical physician.
Patients receiving concurrent other anticancer treatments (radiation or surgery).
Patients with multiple types of cancer requiring simultaneous treatment.