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

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ClinicalTrials.gov Identifier: NCT06055387
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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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:

  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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Behavioral: Frailty intervention measures Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system. [ Time Frame: After completion 3 months treatment. ]
  2. 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. ]

Secondary Outcome Measures :
  1. 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.

  2. To compare overall survival between two distinct groups: frail and non-frail patients. [ Time Frame: up to 1 year. ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055387


Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 330
Contact: Wen-Chi Chou    +8863281200 ext 8426    f12986@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Health and Welfare, Taiwan
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT06055387    
Other Study ID Numbers: 202101510B0C601
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Frailty
Comprehensive Geriatric Assessment (CGA)
Outcome
Radical surgery
Adjuvant chemotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Frailty
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes