Trial results for The Exercise And Colorectal Cancer Treatment Trial were posted on ClinicalTrials.gov on 2025-09-22, involving 60 participants with colorectal cancer.
Background
Colorectal cancer is a significant health concern, and while standard treatments exist, research continues into adjunctive therapies that may improve patient outcomes. Exercise is an area of interest for its potential role in preventing disease recurrence. This trial aimed to investigate the biological mechanisms through which physical activity might influence recurrence in patients who have completed primary treatment for colorectal cancer.
Trial design
This completed study, designated as Phase NA, enrolled 60 participants. The trial investigated patients with Colon Cancer and Rectal Cancer who had completed treatment. The study's objective was to examine the biologic processes through which exercise might prevent disease recurrence. Participants were divided into an exercise group and a control group.
Key results
The trial reported several key measurements and analyses comparing the exercise and control groups:
- For The Percentage Change in High-sensitivity C-reactive Protein:
- The Exercise group showed a mean change of 12.8%.
- The Control group showed a mean change of -6.7%.
- Mixed Models Analysis indicated a Mean Difference (Net) of 20.9, with a 95% Confidence Interval of -17.1 to 76.2, and a p-value of 0.32.
- For The Percentage Change in Interleukin-6:
- The Exercise group showed a mean change of -15.0%.
- The Control group showed a mean change of -5.4%.
- Mixed Models Analysis indicated a Mean Difference (Net) of 11.4, with a 95% Confidence Interval of -7.5 to 34.0, and a p-value of 0.25.
- For The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two:
- The Exercise group showed a mean change of -2.1%.
- The Control group showed a mean change of 1.6%.
- Mixed Models Analysis indicated a Mean Difference (Net) of -3.6, with a 95% Confidence Interval of -13.7 to 7.7, and a p-value of 0.52.
- For The Change in Circulating Tumor Cells Per mL Whole Blood:
- The Aerobic Exercise group showed a mean change of -0.02 cells/mL.
- The Control group showed a mean change of -0.61 cells/mL.
- Mixed Models Analysis indicated a Mean Difference (Net) of 0.59, with a 95% Confidence Interval of -0.33 to 1.51, and a p-value of 0.21.
- For The Percentage Change in Circulating Tumor DNA (Relative to All Cell-free DNA):
- The Exercise group showed a mean change of 0.0011%.
- The Control group showed a mean change of 0.0006%.
- Mixed Models Analysis indicated a Mean Difference (Net) of 0.0005, with a 95% Confidence Interval of -0.0024 to 0.0034, and a p-value of 0.73.
What this means
The results from this trial indicate that the exercise intervention, as studied, did not lead to statistically significant changes in the measured inflammatory biomarkers (high-sensitivity C-reactive protein, interleukin-6, soluble tumor necrosis factor-alpha receptor two) or tumor-related markers (circulating tumor cells, circulating tumor DNA) when compared to the control group. All p-values were above 0.05, suggesting no significant effect of exercise on these specific biological processes in this cohort of colorectal cancer patients. These findings suggest that the specific exercise intervention in this study did not demonstrate a measurable impact on these particular biomarkers of disease recurrence.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03975491, titled "The Exercise And Colorectal Cancer Treatment Trial", were posted on 2025-09-22 on clinicaltrials.gov.