Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

Recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Other: Frailty survey

• Registration Number: NCT05694338
• Lead Sponsor: The Guthrie Clinic

Brief Summary

This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.

Detailed Description

The goals of the study are to:

* Describe the rate of frailty in surgical cancer patients

* Assess if frailty correlates with problems (adverse outcomes) after major surgery

Participants taking part will be asked to complete a survey to assess frailty before surgery. The frailty survey is referred to as the Clinical Risk Analysis Index (RAI-C).

Participants will have about 10 ml (2 teaspoons) of blood drawn before surgery. Blood tests will include complete blood count (CBC), vitamin A, creatinine, C-Reactive Protein (CRP), DHEA, albumin, and prealbumin.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-23
• Study Start: 2023-03-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 years old or older
• histologically proven gastrointestinal malignancy
• referral for elective major surgical procedures at including operations for upper and lower gastrointestinal malignancies and hepato-pancreato-biliary
• referral for neoadjuvant treatment followed by any of the above major surgical procedures

Exclusion Criteria

• under 18 years
• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major surgery for gastrointestinal cancer	Frailty survey	Patients with gastrointestinal cancer who are scheduled for major surgery

Primary Outcome Measures

Name	Time	Method
Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher	pre-operative	Assess Clinical Risk Analysis Index (RAI-C) Scores in rural patients referred for major abdominal surgeries. Survey values will be added to yield a final RAI-C score between 0 and 81. Percent of patients considered frail will be defined as Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher

Secondary Outcome Measures

Name	Time	Method
Adverse outcomes after major surgery	30 days post-operative	Assess adverse outcomes postoperatively and if their is a correlation with the frailty score

Trial Locations

Locations (2)

Guthrie Medical Group; 🇺🇸 E. Corning, New York, United States

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States