The Exercise And Colorectal Cancer Treatment Trial

Rectal Cancer Clinical Trial

— EXACT  

Official title:

The Exercise And Colorectal Cancer Treatment (EXACT) Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03975491
• Other study ID #: PBRC 2019-009
• Secondary ID: R00CA218603
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.

Description:

This randomized trial will examine the biological effects of 12-weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for colorectal cancer. The primary objective is to determine if aerobic exercise can reduce systemic inflammation, quantified using plasma concentrations of high-sensitivity C-reactive protein and interleukin-6. The secondary objectives are to determine if exercise can reduce: 1) insulin resistance quantified using an oral glucose tolerance test, and; 2) circulating tumor cells quantified using a microfluidic antibody-mediated capture platform. The exploratory objective is to determine if exercise can improve mitochondrial respiration rates and fatty acid oxidation in peripheral blood mononuclear cells and tumor fraction.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 30, 2025
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Histologically-confirmed stage I-III colorectal cancer

• Completed surgical resection

• Completed chemotherapy (if applicable)

• Completed radiotherapy (if applicable)

• Provide written approval by physician or other qualified healthcare provider

• No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted)

• Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)

• Allow the collection and storage of specimens and data for future use

• Willing to be randomized

Exclusion Criteria:

• Evidence of metastatic colon cancer

• Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers)

• Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention

• Current body mass greater than or equal to 181 kg

• Unable to provide a baseline fasting blood sample

• Unable or unwilling to give informed consent

• Unable or unwilling to be randomized

• Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms
• Rectal Cancer

Intervention

Behavioral:
• Moderate-Intensity Aerobic Exercise
The exercise intervention will consist of moderate-intensity (50-70% age-predicted maximum heart rate) treadmill walking. All exercise sessions will begin with a five-minute warm up of slow walking, 30-60 minutes of moderate-intensity walking, and a five-minute cool down of slow walking.
• Wait-List Control
Participants randomized into the wait-list control group are asked to maintain their pre-study levels of physical activity and follow the recommendations provided by their physician.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mitochondrial Respiration Rate	Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells)	Baseline, 12 weeks
Other	Fatty Acid Oxidation	Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min)	Baseline, 12 weeks
Other	Tumor Fraction	Proportion of Circulating Tumor DNA (relative to all cell-free DNA)	Baseline, 12 weeks
Primary	High Sensitivity C-Reactive Protein	Concentration of high-sensitivity C-reactive protein (mg/L)	Baseline, 12 weeks
Primary	Interleukin-6	Concentration of interleukin-6 (pg/mL)	Baseline, 12 weeks
Secondary	Soluble Tumor Necrosis Factor-Alpha Receptor Two	Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL)	Baseline, 12 weeks
Secondary	Insulin Resistance	Oral Glucose Tolerance Test (2 hour AUC)	Baseline, 12 weeks
Secondary	Circulating Tumor Cells	Concentration of circulating tumor cells (cells per mL whole blood)	Baseline, 12 weeks