Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer (HBOT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hartford Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00906269
First received: May 19, 2009
Last updated: May 18, 2012
Last verified: April 2011
  Purpose

The purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that delivers oxygen under slight pressure, to a drug treatment of PDE5I (such as Viagra, Levitra, Cialis)for men following surgery for prostate cancer will result in more men being able to continue to have erections.


Condition Intervention Phase
Impotence
Prostatic Neoplasms
Drug: Sildenafil therapy plus post-NSRRP HBO2T
Drug: Sildenafil therapy plus sham post-NSRRP HBO2T
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Erectile function domain of Internation Index of Erectile Function (IIEF) [ Time Frame: 1, 3, 6, 12, and 18 months post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical or biochemical recurrence of cancer [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Sildenafil therapy plus post-NSRRP HBO2T
Sildenafil (Viagra) 50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP hyperbaric oxygen therapy (90 minutes of 100% oxygen at 2.2ATA (equivalent to the pressure exerted at a depth of approximately 40 feet below sea level). There will be 5 or 10 treatments. The full treatment cycle will be completed within 2 weeks.
Other Name: Viagra
Sham Comparator: 2 Drug: Sildenafil therapy plus sham post-NSRRP HBO2T
Sildenafil (Viagra)50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP sham hyperbaric oxygen therapy - 90 minutes at 2.2ATA but instead of 100% oxygen, they will receive air administered via the oxygen hoods, as if they were being administered oxygen. Participants in this group will receive 5 or 10 sham treatment sessions. Full treatment cycle will be completed within 2 weeks.
Other Name: Viagra

Detailed Description:

Prostate cancer is the most common non-skin malignancy in men in the United States, with approximately 232,000 diagnoses of adenocarcinoma projected for 2005. More than 150,000 of these men are treated with radical prostatectomy. Common sequelae following successful NSRRP (nerve-sparing radical retropubic prostatectomy)include urinary incontinence and sexual dysfunction. Recent advances in surgery technique and treatment have been made but in spite of aggressive management, recovery of sexual function is incomplete with fewer than one-fifth reporting return to baseline. The etiology of erectile dysfunction following radical prostatectomy results most probably from local surgical trauma and neurapraxia, which leads to corpus cavernosal hypoxemia in the post-NSRRP period. This hypoxemia is believed to impact negatively on the health and maintenance of the smooth muscle cells within the corpus cavernosum. Hyperbaric oxygen therapy (HBO2T) is a unique modality that is able to provide oxygen delivery to tissues that have been damaged by traumatic injury.

Hypothesis: The addition of post-NSRRP hyperbaric oxygen therapy (HBO2T) to a treatment of phosphodiesterase type 5 inhibitor (PDE5I) will reduce the incidence of erectile dysfunction (ED) and urinary incontinence when measured at 1, 3, 6, 12 and 18 months post-NSRRP for Stage I prostate cancer.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male
  • age 40-69
  • diagnosis of Stage I prostate cancer
  • bilateral NSRRP as primary treatment
  • sexual potency prior to surgery

Exclusion Criteria:

  • COPD, CHF, diabetes mellitus
  • known inability to tolerate PDE5I
  • confinement anxiety/claustrophobia
  • planned adjuvant or neo-adjuvant therapy
  • patients taking alpha blockers or nitrates
  • patients with retinitis pigmentosa
  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: NCT00906269

Contacts
Contact: Alison Champagne, BS 860-545-6049 achampa@harthosp.org
Contact: Ilene Staff, PhD 860-545-0178 IStaff@harthosp.org

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: James Graydon, MD    860-947-8500    jgraydo@harthosp.org   
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: James Graydon, MD Hartford Hospital
  More Information

Additional Information:
Publications:
Feldmeier JJ. Hyperbaric oxygen: does it have a cancer causing or growth enhancing effect? In: Proceeding of the Concensus Conference sponsored by the European Society for Therapeutic Radiology and Oncology and the European Committee for Hyperbaric Medicine. Portugal 2001: 129-146

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00906269     History of Changes
Other Study ID Numbers: STAF001982HU
Study First Received: May 19, 2009
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Hartford Hospital:
impotence
prostatic neoplasms
hyperbaric oxygenation
Phosphodiesterase Inhibitors

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase Inhibitors
Sildenafil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014