Clinical trial NCT03975491: The Exercise And Colorectal Cancer Treatment Trial
Official title: The Exercise And Colorectal Cancer Treatment (EXACT) Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: High Sensitivity C-Reactive Protein
timeFrame: Baseline, 12 weeks
measure: Interleukin-6
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Soluble Tumor Necrosis Factor-Alpha Receptor Two
timeFrame: Baseline, 12 weeks
measure: Insulin Resistance
timeFrame: Baseline, 12 weeks
measure: Circulating Tumor Cells
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Mitochondrial Respiration Rate
timeFrame: Baseline, 12 weeks
measure: Fatty Acid Oxidation
timeFrame: Baseline, 12 weeks
measure: Tumor Fraction
timeFrame: Baseline, 12 weeks
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Justin C Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: