Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

— GEPOC  

Official title:

Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719573
• Other study ID #: 123
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: May 10, 2022

Study information

• Verified date: August 2022
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.

The main aim of the study us to see if the functional decline in this group can be reduced.

Description:

This is a randomized, controlled trial on frail older patients (aged 65 years or older) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• elective surgery for colorectal cancer

• frail

• ability to read and speak danish (informed concent)

Exclusion Criteria:

• any physical condition that hinder physical exercise (eg. no legs)

• not able to concent

Related Conditions & MeSH terms

• Colon Cancer
• Colon Neoplasm
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Frail Elderly Syndrome

Intervention

Other:
• Geriatric intervention
A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Herlev	Region H

Sponsors (3)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	University of Copenhagen, Velux Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-second chair stand test (30s-CST)	functional test measuring lower body strength	baseline to 14 weeks after surgery
Secondary	physical function and capacity - 6-minute-walk-test	6-minute-walk-test	baseline to 14 weeks after surgery
Secondary	physical function and capacity - hand grip strength	hand grip strength	baseline to 14 weeks after surgery
Secondary	physical function and capacity - 6-meter gait speed	6-meter gait speed	baseline to 14 weeks after surgery
Secondary	Patient reported Quality of Life: EORTC	EORTC European Organisation for Research and Treatment of Cancer questionnaire C30 (30-126 points where 30 is the worst)	baseline to 14 weeks after surgery
Secondary	Patient reported Quality of Life: EORTC ELD14	EORTC European Organisation for Research and Treatment of Cancer questionnaire conjoined with ELD14 (Elderly Cancer Patient module) (14-54 points where 54 is the worst)	baseline to 14 weeks after surgery
Secondary	Quality of recovery after surgery: questionnaire	Measured with the questionnaire: Quality of Recovery - 15 questionnaire (0-150 points where 0 points is the worst)	1 day before surgery (baseline) to 3 days after surgery
Secondary	body composition	measured by Bioimpedance assessment	baseline to 14 weeks after surgery.
Secondary	body composition	measured by dual-energy x-ray absorptiometry	baseline to 14 weeks after surgery.
Secondary	inflammatory biomarker - CRP	the concentration of CRP (CRP C-reactive Protein)	baseline to 14 weeks after surgery
Secondary	inflammatory biomarker - Interleukin 6	the concentration of interleukin 6	baseline to 14 weeks after surgery
Secondary	inflammatory biomarker YKL-40	the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)	baseline to 14 weeks after surgery
Secondary	inflammatory biomarkers immuno-oncology	the concentration of 92 proteins associated with immuno-oncology (OLink)	baseline to 14 weeks after surgery
Secondary	sarcopenia biomarker GDF-11	the concentration of GDF-11 (GDF Growth Differentiation Factor)	baseline to 14 weeks after surgery
Secondary	sarcopenia biomarker GDF	the concentration of GDF-15 (GDF Growth Differentiation Factor)	baseline to 14 weeks after surgery
Secondary	Postoperative complications	Measured with Clavien Dindo classification (grade I-V where grade V is death)	30 days + 90 days
Secondary	readmission	Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.	30 days after surgery and 90 days after surgery
Secondary	survival	number of survivors after surgery	10 years
Secondary	mortality	number of patients death	baseline to 3 months
Secondary	number of patients to start up of adjuvant chemotherapy after surgery.	according to guidelines, if physical condition allows it (and patient accepts it).	14 weeks
Secondary	start up time of adjuvant chemotherapy after surgery	measured in days (if relevant)	14 weeks
Secondary	number of series of adjuvant chemotherapy		14 weeks
Secondary	doses of adjuvant chemotherapy		14 weeks