Hyperbaric Oxygenation Treatment and Quality of Life
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|ClinicalTrials.gov Identifier: NCT03570229|
Recruitment Status : Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : July 6, 2018
University of Bergen
Haukeland University Hospital
Information provided by (Responsible Party):
May Aasebø Hauken, University of Bergen
No Study Results Posted on ClinicalTrials.gov for this Study
|Recruitment Status :||Not yet recruiting|
|Estimated Primary Completion Date :||July 8, 2022|
|Estimated Study Completion Date :||August 8, 2022|
Niezgoda 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.
Viswanathan 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. Review.
Do 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.
Plafki 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. Review.
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.
Cancer Registry of Norway. Cancer in Norway 2015 - Cancer incidence, mortality, survival and prevalence in Norway. Oslo: Cancer Registry of Norway; 2016.
Weir G. Hyperbaric oxygen therapy for complications of radiotherapy. Wound Healing South Africa. 2009;2(2):60-62.
Jaeger K, Juttner B. Hyperbaric oxygen therapy. Anasthesiologie & Intensivmedizin. Mar 2003;44(3):187-202.
Macdonald HM. Hyperbaric oxygenation in the patient with malignancy: friend or foe? Diving and Hyperbaric Medicine. 2007;37(3):133-138.
Camporesi EM. Side effects of hyperbaric oxygen therapy. Undersea Hyperb Med. 2014 May-Jun;41(3):253-7. Review.
Ennis RD. Hyperbaric oxygen for the treatment of radiation cystitis and proctitis. Curr Urol Rep. 2002 Jun;3(3):229-31. Review.
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. Review.
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:CD005005. doi: 10.1002/14651858.CD005005.pub4. Review.
Safra T, Gutman G, Fishlev G, Soyfer V, Gall N, Lessing JB, Almog R, Matcievsky D, Grisaru D. Improved quality of life with hyperbaric oxygen therapy in patients with persistent pelvic radiation-induced toxicity. Clin Oncol (R Coll Radiol). 2008 May;20(4):284-7. doi: 10.1016/j.clon.2007.12.005. Epub 2008 Jan 28.
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.
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. Erratum in: J Urol. 2007 Apr;177(4):1588.
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.
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.
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.
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.
Carr JA, Higginson IJ, Robinson PG. Quality of life. London: BMJ Books; 2003.
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.
Löndahl 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.
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.
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.
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.
Lauvrak V, Frønsdal KB, Ormstad SS, Vaagbø 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK390572/
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.
Creswell JW, Clark VL. Designing and conducting mixed method research. London: SAGE Publications, Inc.; 2011.