Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.

Stomach Neoplasms Clinical Trial

Official title:

Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03423056
• Other study ID #: C41030617-091
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: Instituto Nacional de Cancerologia, Columbia
• Contact: Oscar Guevara, MD, MSc
• Phone: 57+14320106
• Email: oguevarac[@]cancer.gov.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures.

It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.

Main objective:

To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.

Materials and methods:

This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment

All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle.

The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.

This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board

Description:

Gastrointestinal - origin cancer is one of the most frequent causes of cancer worldwide ; the primary surgical management is the standard treatment, however, the postoperative complications rate could be up to 35% . Patients with gastrointestinal - origin cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal procedures.

It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.

Main objective:

To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.

Materials and methods:

This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, liver, colon or rectal cancer), scheduled for surgery in 4 weeks or more since recruitment and without electrocardiographic abnormalities.

The patients will be selected from the gastrointestinal unit surgical schedule. The eligible patients will be invited to participate and after their agreement to participate and to do the informed consent process, they will be scheduled to the basal assessment. This aerobic capacity assessment will be done with the 6-minute walk test.

After the basal measurement, two physical therapists will prescribe an individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will be programmed as follows:

• Week 1: heart rate target: 50% of maximum heart rate

• Week 2: heart rate target: 60% of maximum heart rate

• Week 3: heart rate target: 70% of maximum heart rate

• Week 4: heart rate target: 60% of maximum heart rate

The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.

The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.

This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion criteria:

• 45 to 70 years

• Confirmed diagnosis of gastric, hepatic, colon or rectal cancer.

• Live in Bogota for at least 3 months

• Hemoglobin concentration superior to 10g/dL

• Primary surgery date scheduled in the next 4 weeks or more since eligibility assessment

• ECOG score 0 or 1

Exclusion criteria:

• Behavior or cognitive impairment

• musculoskeletal impairment

• any exercise contraindication (fracture or sprains in the last 2 months, severe osteoarthritis, tendinitis)

• Uncontrolled metabolically comorbidities (diabetes, hypertension, hyperlipidemia)

• Presence of obstructive or restrictive pulmonary disease

• Enrolled in another supervised exercise program

• Major electrocardiographic abnormalities.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Gastrointestinal Neoplasms
• Liver Neoplasm
• Liver Neoplasms
• Neoplasms
• Rectal Neoplasms
• Stomach Neoplasms

Intervention

Other:
• Preoperative exercise program
Individualized aerobic training program developed by physical therapist using Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed between 50 to 70% of the maximum heart rate and will be carried on a treadmill or in a stationary bicycle.

Locations

Country	Name	City	State
Colombia	Instituto Nacional de Cancerología	Bogota	Cundinamarca

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia, Columbia	Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen comsumption	peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation	4 weeks after the exercise program beginning
Secondary	exercise-related adverse events	any unexpected reaction secondary to the exercise program. This could be mild (nausea, fall, joint pain, tendinitis) or severe (syncope, fracture, myocardial infarction).	3 and 4 weeks after the exercise program beginning
Secondary	program adherence	frequency of patients who will complete at least the 3 week program.	3 weeks after the exercise program beginning.
Secondary	Peak oxygen comsumption - 3 weeks	peak oxygen consumption measured in ml/kg/min using the American College of Sports	3 weeks after the exercise program beginning