Hyperbaric Oxygenation Treatment and Quality of Life

NCT03570229 | Completed

• 1 other identifier: 01012018
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

Quality of life (QOL); Hyperbaric oxygen treatment (HBOT); Late radiation tissue injury (LRTI); Longitudinal; Mixed methods; Patient experiences

Outcome Measures

Primary Outcomes (1)

• Change in Quality of life after HBO-therapy

  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)

  Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy)

Secondary Outcomes (4)

• Long-term change in Quality of life

  Change from baseline (T1) to 58 weeks (T8, 1 year after end of HBO-therapy)

• Change in Late radiation tissue injury symptoms after HBO-therapy

  Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy)

• Time to improvement in Late radiation tissue injury symptoms

  Time from baseline (T1) to significant improvement (at least 0,5 SD) up to 30 weeks (T7) after end of HBO-therapy

• Satisfaction With Care

  T3 (after 6 weeks)

Interventions

Hyperbaric oxygen treatment OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will recruit participants from all patients with pelvic radiation injury assigned to oxygen treatment (HBOT) at Section for Hyperbaric Medicine (SHM) at Haukeland University Hospital in Bergen, being the Norwegian National Center for planned HBOT.

You may qualify if:

• pelvic radiation injury after intended curative radiation therapy for pelvic cancer (prostate, gynecological, and urological and bowel cancers),
• ≥ 6 months from finished radiation therapy
• referred to the unit for hyperbaric oxgen treatment (HBOT)
• aged ≥ 18 years.

You may not qualify if:

• severe physical and/or mental co-morbidity representing a contraindication for HBOT
• insufficient cognitive or language skills to answer study questionnaires and perform interviews.

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

University of Bergen/Haukeland University Hospital

Bergen, Hordaland, 5013, Norway

Location

Related Publications (33)

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  PMID: 26650092 BACKGROUND

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• Gorenstein 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.

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  BACKGROUND

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• Ennis RD. Hyperbaric oxygen for the treatment of radiation cystitis and proctitis. Curr Urol Rep. 2002 Jun;3(3):229-31. doi: 10.1007/s11934-002-0069-5.

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• Spiegelberg L, Djasim UM, van Neck HW, Wolvius EB, van der Wal KG. Hyperbaric oxygen therapy in the management of radiation-induced injury in the head and neck region: a review of the literature. J Oral Maxillofac Surg. 2010 Aug;68(8):1732-9. doi: 10.1016/j.joms.2010.02.040. Epub 2010 May 20.

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• Bennett MH, Feldmeier J, Hampson NB, Smee R, Milross C. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev. 2016 Apr 28;4(4):CD005005. doi: 10.1002/14651858.CD005005.pub4.

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• Oscarsson N, Arnell P, Lodding P, Ricksten SE, Seeman-Lodding H. Hyperbaric oxygen treatment in radiation-induced cystitis and proctitis: a prospective cohort study on patient-perceived quality of recovery. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):670-5. doi: 10.1016/j.ijrobp.2013.07.039. Epub 2013 Sep 11.

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• van Ophoven A, Rossbach G, Pajonk F, Hertle L. Safety and efficacy of hyperbaric oxygen therapy for the treatment of interstitial cystitis: a randomized, sham controlled, double-blind trial. J Urol. 2006 Oct;176(4 Pt 1):1442-6. doi: 10.1016/j.juro.2006.06.065.

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• Chong V, Rice M. The effectiveness of hyperbaric oxygen therapy (HBOT) in radiation-induced haemorrhagic cystitis. N Z Med J. 2016 Dec 2;129(1446):79-83.

  PMID: 27906922 BACKGROUND

• Ferreira C, Reis F, Correia T, et al. Hyperbaric oxygen for long-term complications of radiation cystitis. Journal of Radiotherapy in Practice. 2014;14(1):18-26.

  BACKGROUND

• Craighead P, Shea-Budgell MA, Nation J, Esmail R, Evans AW, Parliament M, Oliver TK, Hagen NA. Hyperbaric oxygen therapy for late radiation tissue injury in gynecologic malignancies. Curr Oncol. 2011 Oct;18(5):220-7. doi: 10.3747/co.v18i5.767.

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• Glover M, Smerdon GR, Andreyev HJ, Benton BE, Bothma P, Firth O, Gothard L, Harrison J, Ignatescu M, Laden G, Martin S, Maynard L, McCann D, Penny CEL, Phillips S, Sharp G, Yarnold J. Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trial. Lancet Oncol. 2016 Feb;17(2):224-233. doi: 10.1016/S1470-2045(15)00461-1. Epub 2015 Dec 17.

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  BACKGROUND

• Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003 May;56(5):395-407. doi: 10.1016/s0895-4356(03)00044-1.

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• Londahl M, Landin-Olsson M, Katzman P. Hyperbaric oxygen therapy improves health-related quality of life in patients with diabetes and chronic foot ulcer. Diabet Med. 2011 Feb;28(2):186-90. doi: 10.1111/j.1464-5491.2010.03185.x.

  PMID: 21219427 BACKGROUND

• Li G, Hopkins RB, Levine MAH, Jin X, Bowen JM, Thabane L, Goeree R, Fedorko L, O'Reilly DJ. Relationship between hyperbaric oxygen therapy and quality of life in participants with chronic diabetic foot ulcers: data from a randomized controlled trial. Acta Diabetol. 2017 Sep;54(9):823-831. doi: 10.1007/s00592-017-1012-z. Epub 2017 Jun 12.

  PMID: 28603808 BACKGROUND

• Harding SA, Hodder SC, Courtney DJ, Bryson PJ. Impact of perioperative hyperbaric oxygen therapy on the quality of life of maxillofacial patients who undergo surgery in irradiated fields. Int J Oral Maxillofac Surg. 2008 Jul;37(7):617-24. doi: 10.1016/j.ijom.2008.04.004. Epub 2008 May 23.

  PMID: 18501562 BACKGROUND

• Clarke RE, Tenorio LM, Hussey JR, Toklu AS, Cone DL, Hinojosa JG, Desai SP, Dominguez Parra L, Rodrigues SD, Long RJ, Walker MB. Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):134-143. doi: 10.1016/j.ijrobp.2007.12.048. Epub 2008 Mar 14.

  PMID: 18342453 BACKGROUND

• Lauvrak V, Fronsdal KB, Ormstad SS, Vaagbo G, Fure B. Effectiveness of Hyperbaric Oxygen Therapy in Patients with Late Radiation Tissue Injury or Diabetic Foot Ulcer [Internet]. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2015 Mar. Report from Norwegian Knowledge Centre for the Health Services (NOKC) No. 4-2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK390572/

  PMID: 28510406 BACKGROUND

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.

  PMID: 18824488 BACKGROUND

• Creswell JW, Clark VL. Designing and conducting mixed method research. London: SAGE Publications, Inc.; 2011.

  BACKGROUND

• Velure GK, Muller B, Hauken MA. Symptom burden, psychological distress, and health-related quality of life in cancer survivors with pelvic late radiation tissue injuries. Support Care Cancer. 2022 Mar;30(3):2477-2486. doi: 10.1007/s00520-021-06684-x. Epub 2021 Nov 15.

  PMID: 34779920 RESULT

• Hauken MA, Velure GK, Muller B, Sekse RJT. Sexual Health and Quality of Life in Cancer Survivors With Pelvic Radiation Injuries. Cancer Nurs. 2024 Sep-Oct 01;47(5):E298-E307. doi: 10.1097/NCC.0000000000001259. Epub 2023 Jul 14.

  PMID: 37449715 RESULT

• Velure GK, Muller B, Hauken MA. Symptom burden and health-related quality of life six months after hyperbaric oxygen therapy in cancer survivors with pelvic radiation injuries. Support Care Cancer. 2022 Jul;30(7):5703-5711. doi: 10.1007/s00520-022-06994-8. Epub 2022 Mar 23.

  PMID: 35320424 RESULT

• Velure GK, Müller B, Aa. Hauken M. Experiences of patients with pelvic radiation injuries after cancer treatment undergoing hyperbaric oxygen therapy: A phenomenological-hermeneutical study. Nordic Journal of Nursing Research. 2021;41(3):131-9.

  RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• May Aa Hauken, Professor

  University of Bergen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinsipal Investigator

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 26, 2018
• Study Start: August 31, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study has finished, earliest in December 2022
• Access Criteria: On request

Locations

NO (1)