The Exercise And Colorectal Cancer Treatment Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physical Activity in Rectal Cancer Survivors

NCT06435975

Rectal Cancer Rectosigmoid Cancer

COMPLETED NA

ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer

NCT03822572

Colorectal Carcinoma

ACTIVE_NOT_RECRUITING NA

Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy

NCT02597075

Metastatic Colorectal Cancer

TERMINATED NA

Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer

NCT02347852

Colorectal Neoplasms

COMPLETED

Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal Cancer

NCT00975897

Colorectal Cancer

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aerobic Exercise

Moderate-intensity aerobic exercise

Group Type EXPERIMENTAL

Moderate-Intensity Aerobic Exercise

Intervention Type BEHAVIORAL

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.

Control

Wait-list control

Group Type SHAM_COMPARATOR

Wait-List Control

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No