CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 137 enrolled
Drug / intervention
Hyperbaric oxygen treatmentother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03570229
NCT03570229N/ACompleted

Pelvic Radiation Injuries After Cancer Treatment: Symptoms, Quality of Life and Experiences Before, Along and After Hyperbaric Oxygenation Treatment

University of Bergen·observational·Posted Jun 26, 2018·Updated Dec 14, 2023

In Brief

An observational study evaluating Hyperbaric oxygen treatment for Cancer. Completed, enrolled 137 participants across 1 site.

Detailed Summary

Osteoradionecrosis, dermal soft tissue necrosis, radiation cystitis, proctitis and sexual dysfunctions are well-known late-effects after radiation for cancer in the pelvic area, negatively affecting the survivors' quality of life (QOL) and psychosocial wellbeing. Increasing evidence and clinical practice support the use of hyperbaric oxygen treatment (HBOT) as an effective treatment in a variety of radiation injuries, but this is still a field with limited research and knowledge. Especially, there is a knowledge gap on how late radiation tissue injury (LRTI) influences cancer survivors' QOL and psychosocial health in a longitudinal perspective (before, along and after HBOT), as well as the patients' knowledge, expectation and experience from this treatment. This study aims to improve knowledge on these issues.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesNorway

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartAug 31, 2018
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.0 years ago

Interventions

Hyperbaric oxygen treatmentother

Participants in this study will receive hyperbaric oxygen treatment (HBOT) but the investigators do not assign this specific intervention to the study participants. Thus, the patients in this study will receive HBOT as part of routine medical care. Consequently, we regard this as an observational study because the patients will get HBOT independently of the study and they are NOT assigned prospectively to HBOT according to a protocol to evaluate the effects. HBOT for pelvic radiation injury typically involves a treatment pressure of 2.4 ATA (Atmospheres Absolute) breathing oxygen for 90 minutes. The treatment is delivered as series treatment, usually daily treatment up to 30 dives.