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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Behavioral: Frailty intervention measures

Study type: Interventional

Funder types: Other

Identifiers

NCT06055387

202101510B0C601

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Frail group

Experimental group

Description:

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.

Treatment:

Behavioral: Frailty intervention measures

Non-frail group

No Intervention group

Description:

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.