Clinical trial · Observational
Hyperbaric Oxygenation Treatment and Quality of Life
Pelvic Radiation Injuries After Cancer Treatment: Symptoms, Quality of Life and Experiences Before, Along and After Hyperbaric Oxygenation Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperbaric oxygen treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in Quality of life after HBO-therapy
- timeFrame
- Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy)
- description
- Self reported quality of life scale, European Organization for Research and Treatment of Cancer (EORTC QLQ C30) scale, 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest level of functioning/ best score)
Secondary outcomes (4)
- measure
- Long-term change in Quality of life
- timeFrame
- Change from baseline (T1) to 58 weeks (T8, 1 year after end of HBO-therapy)
- description
- Self reported quality of life scale, European Organization for Research and Treatment of Cancer (EORTC QLQ C30) scale, 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest level of functioning/ best score)
- measure
- Change in Late radiation tissue injury symptoms after HBO-therapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. pelvic radiation injury after intended curative radiation therapy for pelvic cancer (prostate, gynecological, and urological and bowel cancers), 2. ≥ 6 months from finished radiation therapy 3. referred to the unit for hyperbaric oxgen treatment (HBOT) 4. aged ≥ 18 years. Exclusion Criteria: 1. severe physical and/or mental co-morbidity representing a contraindication for HBOT 2. insufficient cognitive or language skills to answer study questionnaires and perform interviews.
References
Publications (35)
- BACKGROUNDNiezgoda JA, Serena TE, Carter MJ. Outcomes of Radiation Injuries Using Hyperbaric Oxygen Therapy: An Observational Cohort Study. Adv Skin Wound Care. 2016 Jan;29(1):12-19. doi: 10.1097/01.ASW.0000473679.29537.c0. PMID 26650092
- BACKGROUNDViswanathan AN, Lee LJ, Eswara JR, Horowitz NS, Konstantinopoulos PA, Mirabeau-Beale KL, Rose BS, von Keudell AG, Wo JY. Complications of pelvic radiation in patients treated for gynecologic malignancies. Cancer. 2014 Dec 15;120(24):3870-83. doi: 10.1002/cncr.28849. Epub 2014 Jul 23. PMID 25056522
- BACKGROUNDDo NL, Nagle D, Poylin VY. Radiation proctitis: current strategies in management. Gastroenterol Res Pract. 2011;2011:917941. doi: 10.1155/2011/917941. Epub 2011 Nov 17. PMID 22144997
- BACKGROUNDPlafki C, Carl UM, Glag M, Hartmann KA. The treatment of late radiation effects with hyperbaric oxygenation (HBO). Strahlenther Onkol. 1998 Nov;174 Suppl 3:66-8. PMID 9830461
- BACKGROUNDGorenstein S, Katz A, Regan K, Hangan D. A retrospective case series looking at the effectiveness of hyperbaric oxygen in treating radiation cystitis. Journal of Clinical Oncology. 2015;33(7_suppl):127-127.
- BACKGROUNDCancer Registry of Norway. Cancer in Norway 2015 - Cancer incidence, mortality, survival and prevalence in Norway. Oslo: Cancer Registry of Norway; 2016.
- BACKGROUNDWeir G. Hyperbaric oxygen therapy for complications of radiotherapy. Wound Healing South Africa. 2009;2(2):60-62.
- BACKGROUNDJaeger K, Juttner B, Franko W. [Hyperbaric oxygen therapy--options and limitations]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2002 Jan;37(1):38-42. doi: 10.1055/s-2002-20080. No abstract available. German. PMID 11845381
- BACKGROUNDMacdonald HM. Hyperbaric oxygenation in the patient with malignancy: friend or foe? Diving and Hyperbaric Medicine. 2007;37(3):133-138.