Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial (RICH-ART)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Göteborg University
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01659723
First received: August 2, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The primary objective of this study is to assess the relief of symptoms after Hyperbaric Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate cancer Index Composite (EPIC)symptom estimation scale as primary variable.

Study hypothesis:

  • HBOT can reduce or reverse the change or otherwise limit the damage of the bladder function and/or structure, which arose as a result of radiation therapy of cancer in the pelvic region organs.
  • The effects of HBOT are associated with relief of symptoms that, at least in part, is related to the reduction of the extent of the radiation damage.
  • Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as a sign of an improved function of the mucosa.
  • Treatment results of HBOT remains, in whole or in part, during the follow-up (residual effect)

Condition Intervention Phase
Cystitis, Radio Induced
Drug: Hyperbaric Oxygen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • EPIC (Expanded Prostate cancer Index Composite) [ Time Frame: At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description" ] [ Designated as safety issue: No ]

    EPIC was developed to measure health-related quality of life among men with prostate cancer (22) modified to enhance sensitivity to therapy effects. It comprises four summary domains; urinary, bowel, sexual and hormonal.

    The primary objective of this study is to assess the relief of symptoms after HBOT in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable, comparing results between group A (post treatment) and group B (pre treatment).

    All patients (Group A and B) will complete EPIC and SF-36 in a post-study long-term follow-up. This is done yearly for 5 years (18, 30, 42, 54 and 66 months post inclusion).



Secondary Outcome Measures:
  • Microscopic assessment [ Time Frame: At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) ] [ Designated as safety issue: No ]
    To investigate the mucosa with respect to functionality by assessment of inflammation activity, quantification of fibrosis, vascular density and the presence of stems cells having histological analysis from biopsies as variable. Comparison will be made between group A (post treatment) and group B (pre treatment)

  • RTOG (Radiation Toxicity Grade by Radiation Therapy Oncology Group) [ Time Frame: At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) ] [ Designated as safety issue: No ]

    RTOG is an internationally well established research group in the oncology field. They have developed organ specific scales for quantification of both acute and late symptoms after radiation. The scale range is from 0 to 5, where 0 is used for normal function and findings and 5 for death directly related to injuries post radiation. Both subjective and objective findings are used when setting the score.

    Comparison will be made between Group A (post treatment) and Group B (pre treatment)


  • SF-36 (Short Form Health Survey 36) [ Time Frame: At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description" ] [ Designated as safety issue: No ]

    SF-36 is a self-administered questionnaire and contains 36 items which measure eight dimensions and assess health-related quality of life. Comparing results between Group A (post treatment) and Group B (pre treatment).

    All patients (Group A and B) will complete EPIC and SF-36 in a post-study long-term follow-up. This is done yearly for 5 years (18, 30, 42, 54 and 66 months post inclusion).


  • Adverse events [ Time Frame: Every day during HBOT (8 weeks). ] [ Designated as safety issue: Yes ]
    Adverse events (AE) and Serious adverse events (SAE) will be recorded.


Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A - Immediate start
Start of treatment within 6 weeks of inclusion in the study. 100% oxygen at 240-250 kPa will be delivered to the patents for 80-90 minutes while sitting or lying in a hyperbaric oxygen chamber. Patients will receive treatment once every day, except week-ends, for 40 days.
Drug: Hyperbaric Oxygen
100% oxygen at 240-250 kPa will be delivered to the patents for 80-90 minutes while sitting or lying in a hyperbaric oxygen chamber. Patients will receive treatment once every day, except week-ends, for 40 days.
No Intervention: B - delayed start
Delayed start: Start of treatment not before 6 months of inclusion in the study. No intervention is given during the initial period.

Detailed Description:

Radiotherapy is commonly used in the management of malignant diseases. Despite a continuous improvement of the technique, with improved efficacy and tolerance, adverse effects are still rather common. The urinary bladder and rectum are the major organs most commonly affected by radiotherapy to the pelvis area.

One of the most significant causes of the symptoms of radio therapy is inflammation and degeneration of blood vessels in the radiated tissue. Hyperbaric oxygen therapy involves administration of oxygen at greater than normal atmospheric pressures. A well-documented effect of HBOT is the stimulation of angiogenesis. HBOT is an established treatment for degeneration of blood vessels in the jaw bone as a result of radiotherapy and several publications have shown good efficacy also when soft tissue is affected.

If the method of treatment with HBOT means a reduction of the radiotherapy side effect it is thus an obvious importance for the individual patient. There is also significant potential savings for the healthcare and society.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Female or male aged 18-80 years
  • Intended curative radiation of the pelvic region as a treatment for cancer
  • End of radiation therapy more than 6 months ago
  • Radiation cystitis with Urological EPIC < 80

Exclusion Criteria:

  • Patients with major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks)
  • Refractory incontinence requiring catheter or surgical intervention
  • Urine bladder capacity < 100ml
  • Fistula in the urine bladder
  • Contraindications for HBOT according to the local centres routines
  • Pregnancy
  • Mechanical ventilator support
  • Unable to follow and understand simple commands
  • Not oriented to person, place and time
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659723

Contacts
Contact: Nicklas Oscarsson, MD +46 31 343 42 13 nicklas.oscarsson@vgregion.se
Contact: Per Arnell, MD +46 31 343 60 22 per.arnell@vgregion.se

Locations
Denmark
Rigshospitalet Copenhagen Not yet recruiting
Copenhagen, Denmark
Contact: Erik Jansen, MD    +45 3545 3545    erik.jansen@rh.regionh.dk   
Principal Investigator: Erik Jansen, MD         
Norway
Haukeland Universitetssykehus Not yet recruiting
Bergen, Norway
Contact: Guro Vaagbø, MD    +47 55973974    guro.vaagbo@helse-bergen.no   
Principal Investigator: Guro Vaagbø, MD         
Sweden
Shalgrenska University Hospial Recruiting
Gothenburg, Sweden
Contact: Nicklas Oscarsson, MD    +46 31 343 42 13    nicklas.oscarsson@vgregion.se   
Principal Investigator: Nicklas Oscarsson, MD         
Sub-Investigator: Anders Rosén, MD         
Sub-Investigator: Per Arnell, MD         
Landstinget Blekinge Not yet recruiting
Karlskrona, Sweden
Contact: Ylva Holm, MD    +46(0)455-73 10 00      
Principal Investigator: Ylva Holm, MD         
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Contact: Folke Lind, MD    +46(0)70-450 77 52    folke.lind@karolinska.se   
Principal Investigator: Folke Lind, MD         
NU-sjukvården Not yet recruiting
Uddevalla, Sweden
Contact: Lars Spetz, MD    +46 (0)10 - 473 81 00    lars.spetz@vgregion.se   
Principal Investigator: Lars Spetz, MD         
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Nicklas Oscarsson, MD Sahlgrenska, Gothenburg University
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01659723     History of Changes
Other Study ID Numbers: RICH-ART 2012-001381-15, 2012-001381-15
Study First Received: August 2, 2012
Last Updated: June 25, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Göteborg University:
Radio therapy
STRI
Urinary bladder
Hyperbaric Oxygen

Additional relevant MeSH terms:
Cystitis
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014