The Exercise And Colorectal Cancer Treatment Trial

The Exercise And Colorectal Cancer Treatment (EXACT) Trial

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03975491

Acronym

EXACT

Enrollment

Registered

2019-06-05

Start date

2019-08-01

Completion date

2026-01-01

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Rectal Cancer

Brief summary

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

Detailed 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.

Interventions

BEHAVIORALModerate-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.

BEHAVIORALWait-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
The Percentage Change in High-sensitivity C-reactive Protein	Baseline, 12 weeks
The Percentage Change in Interleukin-6	Baseline, 12 weeks

Secondary

Measure	Time frame	Description
The Change in Circulating Tumor Cells Per mL Whole Blood	Baseline, 12 weeks	—
The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two	Baseline, 12 weeks	—
Insulin Resistance	Baseline, 12 weeks	Oral Glucose Tolerance Test (2 hour AUC)

Other

Measure	Time frame	Description
Mitochondrial Respiration Rate	Baseline, 12 weeks	Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells)
Fatty Acid Oxidation	Baseline, 12 weeks	Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min)
The Percentage Change in Circulating Tumor DNA (Relative to All Cell-free DNA)	Baseline, 12 weeks	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Exercise Aerobic Exercise	31
Control Waitlist Control	29
Total	60

Baseline characteristics

Characteristic	Total	Exercise	Control
Age, Continuous	60.6 years STANDARD_DEVIATION 10.8	62.3 years STANDARD_DEVIATION 10.9	58.6 years STANDARD_DEVIATION 10.6
Circulating Tumor Cells	1.5 cells/mL STANDARD_DEVIATION 2	1.6 cells/mL STANDARD_DEVIATION 1.9	1.5 cells/mL STANDARD_DEVIATION 2.2
High Sensitivity C-Reactive Protein	2.5 mg/L STANDARD_DEVIATION 2.1	2.6 mg/L STANDARD_DEVIATION 2.1	2.4 mg/L STANDARD_DEVIATION 2.2
Interleukin-6	4.8 pg/mL STANDARD_DEVIATION 4.1	6.2 pg/mL STANDARD_DEVIATION 4.2	3.8 pg/mL STANDARD_DEVIATION 3.9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	10 Participants	6 Participants	4 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants	3 Participants	2 Participants
Race (NIH/OMB) White	45 Participants	22 Participants	23 Participants
Sex: Female, Male Female	39 Participants	20 Participants	19 Participants
Sex: Female, Male Male	21 Participants	11 Participants	10 Participants
Soluble Tumor Necrosis Factor-Alpha Receptor Two	5954.4 pg/mL STANDARD_DEVIATION 1.5	6307.7 pg/mL STANDARD_DEVIATION 1.4	5598.5 pg/mL STANDARD_DEVIATION 1.4
Tumor Fraction	0.010 % cells of tumor origin (of all cfDNA) STANDARD_DEVIATION 0.007	0.009 % cells of tumor origin (of all cfDNA) STANDARD_DEVIATION 0.003	0.012 % cells of tumor origin (of all cfDNA) STANDARD_DEVIATION 0.009

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 31	1 / 29
other Total, other adverse events	0 / 31	0 / 29
serious Total, serious adverse events	0 / 31	0 / 29