Table 3.
Patient characteristics at pretrial eligibility assessments
| Sham control (n=29) | Hyperbaric oxygen (n=55) | |
|---|---|---|
| Age | ||
| Mean | 62·0 (11) | 62·3 (11) |
| Median | 63·7 (53·6–69·9) | 63·7 (53·9–71·2) |
| Range | 37·3–79·3 | 34·5–80·9 |
| Sex | ||
| Male | 14 (48%) | 23 (42%) |
| Female | 15 (52%) | 32 (58%) |
| Origin of cancer | ||
| Prostate | 12 (41%) | 21 (38%) |
| Anus | 4 (14%) | 4 (7%) |
| Vagina | 3 (10%) | 1 (2%) |
| Cervix | 5 (17%) | 17 (31%) |
| Uterus | 3 (10%) | 8 (15%) |
| Other* | 2 (7%) | 4 (7%) |
| Medical history | ||
| Back pain | 3 (10%) | 7 (13%) |
| Bloating | 18 (62%) | 30 (55%) |
| Constipation | 5 (17%) | 5 (9%) |
| Cramps or abdominal pain | 14 (48%) | 38 (69%) |
| Diarrhoea | 14 (48%) | 30 (55%) |
| Faecal incontinence | 19 (66%) | 35 (64%) |
| Frequency | 18 (62%) | 38 (69%) |
| Mucus discharge | 10 (34%) | 21 (38%) |
| Nausea | 4 (14%) | 13 (24%) |
| Other | 6 (21%) | 8 (15%) |
| Rectal bleeding | 23 (79%) | 34 (62%) |
| Rectal or perineal pain | 8 (28%) | 10 (18%) |
| Steatorrhoea | 1 (3%) | 10 (18%) |
| Subacute obstructive symptoms | 3 (10%) | 14 (25%) |
| Tenesmus | 18 (62%) | 35 (64%) |
| Unable to differentiate need to defecate or pass urine | 1 (3%) | 2 (4%) |
| Unable to differentiate solid or liquid stool | 6 (21%) | 11 (20%) |
| Urgency | 20 (69%) | 48 (87%) |
| Weight loss | 2 (7%) | 10 (18%) |
| Wind | 17 (59%) | 39 (71%) |
| Time since pelvic radiotherapy (years) | ||
| Median | 3·9 (2·5–5·7) | 3·5 (2·3–9·7) |
| Range | 1·5–21·2 | 1·2–34·0 |
Data are n (%) or median (IQR).
*
Others were anal canal (n=1) and vulva (n=1) in the control group and retroperitoneum (n=1), pelvis (n=1), rectum (n=1), and bladder (n=1) in the hyperbaric oxygen therapy group.