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Hyperbaric Oxygenation Treatment and Quality of Life

NCT03570229 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 137

Last updated 2023-12-14

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Hyperbaric oxygen treatment

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.

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • University of Bergen

    lead OTHER

Principal Investigators

  • May Aa Hauken, Professor · University of Bergen

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570229 on ClinicalTrials.gov