Clinical Trial: HBOT Late Radiation Tissue Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational




Official Title: Does Hyperbaric Oxygen Therapy (HBOT) Reduce Pain, Improve Depression and Impact on Patients' Quality of Life for Those Suffering From Late Radiation Tissue Injury?

Brief Summary:

Background: Radiotherapy is a common treatment for many malignancies. Radiation-related complications developing months or years after radiation treatment are known as late radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors who have received radiation.

Hyperbaric oxygen therapy (HBOT) is a well established treatment of LRTI. Most of the studies evaluating effect of HBOT on LRTI are focused on survival, resolution of tissue damage and improvement in LENT-SOMA scale. Very few studies have addressed effect of HBOT on pain in LTRI. Krahn and colleagues were the first to report the analgesic effect of HBOT in 3 cases of refractory pain in oncological patients with radiation soft tissue injury. Other studies showed significant improvement in pain intensity in patients with breast cancer and pelvic malignancies treated with HBOT for LTRI. In patients that had developed radiation- induced brachial plexopathy, HBOT elicited an increase in warm pain thresholds and a reduction in lymphoedema. A prospective case study of 16 patients with gynecological cancer found no changes with respect to pain and depression outcomes. A trial in patients with radiation induced proctopathy showed that 75% of patients with rectal pain had some improvement, although none experienced a complete resolution of pain symptoms.

There are several mechanisms by which HBOT may elicit analgesic effects. There is a growing body of evidence that HBOT's analgesic effect related to nitric oxide metabolism and endogenous opioid secretion. Furthermore, the inhibition of tumor necrosis factor alph (TNF-α), the production of substance P, and the modulation of serotonergic pathways have all demonstrated a modification in the pain response following HBOT. In animal studies HBOT decreased allodynia and hyperalgesia in differen