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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
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
May Aasebø Hauken, University of Bergen

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.

Condition or disease Intervention/treatment
Cancer Other: Hyperbaric oxygen treatment

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pelvic Radiation Injuries After Cancer Treatment: Symptoms, Quality of Life and Experiences Before, Along and After Hyperbaric Oxygenation Treatment
Estimated Study Start Date : August 6, 2018
Estimated Primary Completion Date : July 8, 2022
Estimated Study Completion Date : August 8, 2022

Intervention Details:
  • 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.



Primary Outcome Measures :
  1. Change in Quality of life after HBO-therapy [ Time Frame: Change from baseline (T1) to 30 weeks (T7, 6 months after end of 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)


Secondary Outcome Measures :
  1. Long-term change in Quality of life [ Time Frame: Change from baseline (T1) to 58 weeks (T8, 1 year after end of 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)

  2. Change in Late radiation tissue injury symptoms after HBO-therapy [ Time Frame: Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy) ]
    Expanded Prostate Cancer Index (EPIC) questionnaire, urinary (12 items) and bowel (14 items) subscores, 3- to 5-point Likert scale, sum-score 0-100 (0=worst symptoms)

  3. Time to improvement in Late radiation tissue injury symptoms [ Time Frame: Time from baseline (T1) to significant improvement (at least 0,5 SD) up to 30 weeks (T7) after end of HBO-therapy ]
    Expanded Prostate Cancer Index (EPIC) questionnaire, urinary (12 items) and bowel (14 items) subscores, 3- to 5-point Likert scale, sum-score 0-100 (0=worst symptoms), improvement defined as a higher score of at least 0,5 standard deviations based on the study population

  4. Satisfaction With Care [ Time Frame: T3 (after 6 weeks) ]
    Total score of EORTC in-PATSAT 32 (European Organization of Research and Treatment of Cancer, In-patient satisfaction With care), 32 questions, 5-point Likert scale, total score 0-100, higher score = more satisfied with care



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570229


Contacts
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Contact: May Aa Hauken, PhD +4741549612 May.hauken@uib.no
Contact: Grete Velure, Msci +4755973901 grete.velure@helse-bergen.no

Locations
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Norway
University of Bergen/Haukeland University Hospital Not yet recruiting
Bergen, Hordaland, Norway, 5013
Contact: May Aa Hauken, PhD    +4741549612    may.hauken@uib.no   
Contact: Grete K Velure, RN/MSci    +4755973901    grete.velure@helse_bergen.no   
Principal Investigator: May Aa Hauken, PhD         
Principal Investigator: Grete K Velure, MSCi         
Principal Investigator: Bernd Mueller, Dr. med/PhD         
Sub-Investigator: Synnøve Andersen, RN         
Sub-Investigator: Tone Merete Jansen, RN         
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
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Study Chair: May Aa Hauken, PhD University of Bergen

Publications:
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.
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.
Carr JA, Higginson IJ, Robinson PG. Quality of life. London: BMJ Books; 2003.
Creswell JW, Clark VL. Designing and conducting mixed method research. London: SAGE Publications, Inc.; 2011.

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Responsible Party: May Aasebø Hauken, Prinsipal Investigator, University of Bergen
ClinicalTrials.gov Identifier: NCT03570229     History of Changes
Other Study ID Numbers: 01012018
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to make IPD available to other researchers on NSD (Norwegian Scientific Data).
Supporting Materials: Study Protocol
Time Frame: After the study has finished, earliest in December 2022
Access Criteria: On request
URL: http://www.nsd.uib.no/nsd/english/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by May Aasebø Hauken, University of Bergen:
Quality of life (QOL)
Hyperbaric oxygen treatment (HBOT)
Late radiation tissue injury (LRTI)
Longitudinal
Mixed methods
Patient experiences