Trial Outcomes & Findings for The Exercise And Colorectal Cancer Treatment Trial (NCT NCT03975491)

NCT ID: NCT03975491

Last Updated: 2025-09-22

Results Overview

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline, 12 weeks
• Results posted on: 2025-09-22

Participant Flow

Participant milestones

Measure	Exercise Aerobic Exercise	Control Waitlist Control
Overall Study STARTED	31	29
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Exercise And Colorectal Cancer Treatment Trial

Baseline characteristics by cohort

Measure	Exercise n=31 Participants Aerobic Exercise	Control n=29 Participants Waitlist Control	Total n=60 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 10.9 • n=5 Participants	58.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	60.6 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
High Sensitivity C-Reactive Protein	2.6 mg/L STANDARD_DEVIATION 2.1 • n=5 Participants	2.4 mg/L STANDARD_DEVIATION 2.2 • n=7 Participants	2.5 mg/L STANDARD_DEVIATION 2.1 • n=5 Participants
Interleukin-6	6.2 pg/mL STANDARD_DEVIATION 4.2 • n=5 Participants	3.8 pg/mL STANDARD_DEVIATION 3.9 • n=7 Participants	4.8 pg/mL STANDARD_DEVIATION 4.1 • n=5 Participants
Soluble Tumor Necrosis Factor-Alpha Receptor Two	6307.7 pg/mL STANDARD_DEVIATION 1.4 • n=5 Participants	5598.5 pg/mL STANDARD_DEVIATION 1.4 • n=7 Participants	5954.4 pg/mL STANDARD_DEVIATION 1.5 • n=5 Participants
Circulating Tumor Cells	1.6 cells/mL STANDARD_DEVIATION 1.9 • n=5 Participants	1.5 cells/mL STANDARD_DEVIATION 2.2 • n=7 Participants	1.5 cells/mL STANDARD_DEVIATION 2.0 • n=5 Participants
Tumor Fraction	0.009 % cells of tumor origin (of all cfDNA) STANDARD_DEVIATION 0.003 • n=5 Participants	0.012 % cells of tumor origin (of all cfDNA) STANDARD_DEVIATION 0.009 • n=7 Participants	0.010 % cells of tumor origin (of all cfDNA) STANDARD_DEVIATION 0.007 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Measure	Exercise n=31 Participants Aerobic Exercise	Control n=28 Participants Waitlist Control
The Percentage Change in High-sensitivity C-reactive Protein	12.8 % change Interval -13.1 to 46.3	-6.7 % change Interval -28.9 to 22.4

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Measure	Exercise n=31 Participants Aerobic Exercise	Control n=28 Participants Waitlist Control
The Percentage Change in Interleukin-6	-15.0 % change Interval -25.4 to -3.2	-5.4 % change Interval -17.0 to 7.9

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Measure	Exercise n=31 Participants Aerobic Exercise	Control n=28 Participants Waitlist Control
The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two	-2.1 % change Interval -9.3 to 5.7	1.6 % change Interval -6.2 to 10.0

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Measure	Exercise n=31 Participants Aerobic Exercise	Control n=28 Participants Waitlist Control
The Change in Circulating Tumor Cells Per mL Whole Blood	-0.02 cells/mL Interval -0.56 to 0.52	-0.61 cells/mL Interval -1.36 to 0.14

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Oral Glucose Tolerance Test (2 hour AUC)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Measure	Exercise n=31 Participants Aerobic Exercise	Control n=28 Participants Waitlist Control
The Percentage Change in Circulating Tumor DNA (Relative to All Cell-free DNA)	0.0011 % change Interval -0.0009 to 0.0031	0.0006 % change Interval -0.0015 to 0.0027

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12 weeks

Respiration rate in peripheral blood mononuclear cells (pmol O2/sec/million cells)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12 weeks

Oxidation rate in peripheral blood mononuclear cells (mmol/mg/min)

Outcome measures

Outcome data not reported

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Justin Brown

Pennington Biomedical Research Center

Phone: 2257632715

Email: Justin.Brown@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place