Glover, M., Smerdon, G.R., Andreyev, H.J., Benton, B.E., Bothma, P., Firth, O., . . . Yarnold, J. (2016). Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): A randomised, double-blind, sham-controlled phase 3 trial. Lancet Oncology, 17, 224–233.

DOI Link

doi: 10.1016/S1470-2045(15)00461-1

Study Purpose

To determine the clinical benefit of hyperbaric oxygen therapy on the management of bowel dysfunction in patients who receive radiation therapy to the pelvis

Intervention Characteristics/Basic Study Process

Study of patients with chronic gastrointestinal problems for greater than 12 months post radiation therapy in spite of optimal medical management. Patients received either hyperbaric oxygen therapy or sham.

Sample Characteristics

N = 84
AGE = 62 years
MALES: 44%, FEMALES: 56%
CURRENT TREATMENT: Radiation
KEY DISEASE CHARACTERISTICS: Past therapy with pelvic radiation for treatment of gynecologic, prostate, or anal cancer

Setting

SITE: Multi-site
SETTING TYPE: Outpatient
LOCATION: U.K.

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Double-blinded, sham-controlled, phase 3, randomized trial

Measurement Instruments/Methods

Inflammatory Bowel Disease Questionnaire (IBDQ)
IBDQ rectal bleeding

Results

No difference between treatment groups existed.

Conclusions

In this patient group, no improvement using hyperbaric oxygen versus sham occurred.

Limitations

Small sample (< 100)
Intervention expensive, impractical, or training needs

Nursing Implications

Large randomized, phase 3 studies are required before any conclusions can be made about the use of hyperbaric oxygen in patients with bowel dysfunction after radiation therapy.