Baseline patient demographic, clinical, behavioural and randomisation characteristics, overall and stratified by physical activity category
Characteristic | Total cohort | Physically active | Physically inactive | P Value |
N=1696 (100.0%) | N=795 (46.9%) | N=901 (53.1%) | ||
Demographic factors | ||||
Age, years, mean (SD) | 60.8 (10.6) | 59.8 (10.4) | 61.6 (10.7) | <0.001 |
Female, n (%) | 755 (44.5) | 297 (37.4) | 458 (50.8) | <0.001 |
Race, n (%) | <0.001 | |||
White | 1378 (81.3) | 688 (86.5) | 690 (76.6) | |
Black or African American | 195 (11.5) | 56 (7.0) | 139 (15.4) | |
Asian | 62 (3.7) | 27 (3.4) | 35 (3.9) | |
All others or not reported | 61 (3.6) | 24 (3.0) | 37 (4.1) | |
Hispanic or Latino, n (%) | 99 (5.8) | 37 (4.7) | 62 (6.9) | 0.051 |
Clinical factors | ||||
Extent of invasion through the bowel wall, n (%)* | 0.088 | |||
T1 or T2 | 312 (18.6) | 163 (20.5) | 149 (16.5) | |
T3 | 1123 (66.8) | 518 (65.2) | 605 (67.1) | |
T4 | 245 (14.6) | 107 (13.5) | 138 (15.3) | |
Missing | 16 | 7 (0.9) | 9 (1.0) | |
Nodal stage, n (%)† | 0.051 | |||
N1 | 1240 (73.1) | 599 (75.3) | 641 (71.1) | |
N2 | 456 (26.9) | 196 (24.7) | 260 (28.9) | |
Risk group, n (%) | 0.053 | |||
Low (T1, T2 or T3, N1) | 1068 (63.6) | 520 (65.4) | 548 (60.8) | |
High (T4, N2 or both) | 612 (36.4) | 268 (33.7) | 344 (38.2) | |
Missing | 16 | 7 (0.9) | 9 (1.0) | |
Tumour location, n (%) | 0.07 | |||
Left | 805 (47.9) | 396 (49.8) | 409 (45.4) | |
Right/transverse/multiple | 876 (52.1) | 391 (50.2) | 485 (55.6) | |
Missing | 15 | 8 (1.0) | 7 (0.8) | |
ECOG performance status, n (%)‡ | <0.001 | |||
0 | 1220 (71.9) | 638 (80.3) | 582 (64.6) | |
1–2 | 476 (28.1) | 157 (19.7) | 319 (35.4) | |
Low-dose aspirin use, n (%) | 386 (22.8) | 180 (22.6) | 206 (22.9) | 0.91 |
Behavioural factors§ | ||||
Body mass index, kg/m2, mean (SD) | 28.3 (6.6) | 27.5 (5.74) | 29.1 (7.11) | <0.001 |
Smoking history, n (%) | 0.029 | |||
Never | 840 (49.5) | 416 (52.3) | 424 (47.1) | |
Former | 701 (41.3) | 322 (40.5) | 379 (42.1) | |
Current | 129 (7.6) | 48 (6.0) | 81 (9.0) | |
Not reported | 26 (1.5) | 9 (1.1) | 17 (1.9) | |
Western dietary pattern, n (%) | 0.63 | |||
< Median | 851 (50.2) | 394 (49.6) | 457 (50.7) | |
≥ Median | 845 (49.8) | 401 (50.4) | 444 (49.3) | |
Prudent dietary pattern, n (%) | <0.001 | |||
< Median | 847 (49.9) | 317 (39.9) | 530 (58.8) | |
≥ Median | 849 (50.1) | 478 (60.1) | 371 (41.2) | |
Physical activity, MET-h/wk | ||||
Mean (SD) | 16.1 (24.1) | 31.1 (28.5) | 2.82 (2.60) | <0.001 |
Median (IQR) | 7.6 (2.0–20.0) | 21.5 (13.9–38.8) | 2.2 (0.4–4.8) | <0.001 |
Randomisation groups | ||||
Chemotherapy, n (%) | 0.44 | |||
3 Months | 879 (51.8) | 420 (52.8) | 459 (50.9) | |
6 Months | 817 (48.2) | 375 (47.2) | 442 (49.1) | |
Pharmacotherapy, n (%) | 0.59 | |||
Celecoxib | 861 (50.8) | 398 (50.1) | 463 (51.4) | |
Placebo | 835 (49.2) | 397 (49.9) | 438 (48.6) |
*T1 indicates that the tumour has grown into the submucosa; T2, growth into the muscularis propria; T3, growth through the muscularis propria and into the subserosa; T4, growth into the surface of the visceral peritoneum or into or has attached to other organs or structures.
†N1 indicates 1 to 3 lymph nodes tested positive for cancer (or for this table, N1c: tumour deposit(s) in the subserosa, mesentery or non-peritonealised pericolic or perirectal tissues without regional lymph node metastases); N2, four or more lymph nodes tested positive for cancer.
‡Performance status: 0 indicates fully active; 1, restricted in physically strenuous activity but ambulatory and able to carry out light work; and 2, ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours.
§Body mass index, western dietary pattern, prudent dietary pattern and physical activity were calculated using the cumulative average method.
ECOG, Eastern Cooperative Oncology Group.