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

February 11, 2025 updated by: Chang Gung Memorial Hospital

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:

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 330
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system.
Time Frame: After completion 3 months treatment.
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.
Time Frame: After completion 3 months treatment.
After completion 3 months treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: After completion 6 months treatment.
The frail group will receive management and recommendations based on the specific impairment domain.
After completion 6 months treatment.
To compare overall survival between two distinct groups: frail and non-frail patients.
Time Frame: up to 1 year.
up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Health and Welfare, Taiwan

Study record dates

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 Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101510B0C601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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