Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06040801

Effect of Geriatric Intervention in Frail Patients with Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy

Led by Chang Gung Memorial Hospital · Updated on 2025-02-13

138

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Gastric, biliary, and pancreatic cancers are common gastrointestinal cancers in Taiwan, often diagnosed at advanced stages when surgery is not an option. Palliative chemotherapy is a standard treatment to help extend survival and improve quality of life. However, elderly patients often receive less or lower doses of chemotherapy due to concerns about age, other health issues, and treatment side effects. This trial focuses on selecting elderly patients appropriately for chemotherapy by assessing frailty, which affects treatment tolerance and outcomes. Participants will undergo a frailty assessment within seven days before starting their first cycle of palliative chemotherapy. Based on this assessment, patients identified as frail (with impairments in at least two areas) will receive tailored geriatric interventions addressing functional status, nutrition, comorbidities, mobility, mood, cognition, medication use, and social support. Non-frail patients will receive standard care without additional interventions. The study compares chemotherapy tolerance, treatment-related toxicity, and quality of life between frail and non-frail groups. During the study, patients will be monitored for chemotherapy completion rates over three months, and adverse events will be assessed using standard criteria. Quality of life will be measured before and after treatment using validated questionnaires. Researchers will also observe treatment-related toxicity and the impact of geriatric interventions on these outcomes. Participation lasts at least three months, with evaluations focused on chemotherapy tolerance and patient well-being.

CONDITIONS

Brief Title

Effect of Geriatric Intervention in Frail Patients with Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 65 years or older with metastatic or unresectable gastric, biliary, or pancreatic cancer
  • Signed informed consent form
  • Estimated survival period of more than 3 months
  • Conscious and able to communicate verbally or in writing, willing to cooperate with invasive procedures
Not Eligible

You will not qualify if you...

  • Cognitive impairment or inability to cooperate with interventional procedures as determined by a clinical physician
  • Receiving concurrent anticancer treatments such as radiation or surgery
  • Having multiple types of cancer requiring simultaneous treatment
  • Previously participated in this study during an earlier chemotherapy regimen

AI-Screening

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Your Study Journey

Screening

Duration - Up to 7 days before starting chemotherapy

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Approximately 3 months

Participants receive palliative chemotherapy. Frail participants receive additional geriatric interventions based on their specific impairments in areas such as functional status, nutrition, mobility, mood, and cognition.

Visits aligned with chemotherapy cycles over 3 months

Follow-up

Duration - After completion of 3 months of chemotherapy treatment

Participants are assessed for chemotherapy completion, adverse events, treatment-related toxicity, and quality of life after treatment.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan, 330

Actively Recruiting

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Research Team

W

Wen-Chi Chou, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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