Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01087268
First received: March 13, 2010
Last updated: July 14, 2011
Last verified: March 2010
  Purpose

RATIONALE: Radiation therapy can cause long-term adverse effects. Hyperbaric oxygen therapy may be effective in lessening gastrointestinal symptoms caused by radiation therapy given for pelvic cancer. It is not yet known whether high-pressure oxygen is effective in treating adverse effects caused by radiation therapy.

PURPOSE: This randomized phase III trial is studying hyperbaric oxygen therapy to see how well it works in treating long-term gastrointestinal adverse effects caused by radiation therapy in patients with pelvic cancer.


Condition Intervention Phase
Bladder Cancer
Cervical Cancer
Colorectal Cancer
Endometrial Cancer
Gastrointestinal Complications
Long-term Effects Secondary to Cancer Therapy in Adults
Ovarian Cancer
Prostate Cancer
Radiation Toxicity
Sarcoma
Testicular Germ Cell Tumor
Vaginal Cancer
Other: questionnaire administration
Procedure: gastrointestinal complications management/prevention
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Randomized Double-Blind Controlled Phase III Trial of Hyperbaric Oxygen Therapy in Patients Suffering Long-Term Adverse Effects of Radiotherapy for Pelvic Cancer (HOT II)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician assessment of adverse effects using LENT SOMA scales of radiation injury [ Designated as safety issue: Yes ]
  • Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38 [ Designated as safety issue: No ]
  • Photographic images of rectal mucosa [ Designated as safety issue: No ]
  • Physician assessment of rectal dysfunction based on the modified CTCAE grading system [ Designated as safety issue: No ]
  • Health economics data [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine the clinical benefits of hyperbaric oxygen therapy in reducing dysfunction in patients with pelvic cancer developing iatrogenic gastrointestinal symptoms as a result of previous radical pelvic radiotherapy completed at least one year ago.

OUTLINE: This is a multicenter study. Patients are stratified according to center and severity of symptoms (low vs high). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (treatment group): Patients undergo hyperbaric oxygen therapy over 90 minutes, 5 days a week, for 8 weeks for a total of 40 treatments. Oxygen at 100% is breathed for 30 minutes, followed by a 5-minute "air break" and a further 30 minutes of breathing oxygen. A further 5-minute "air break" is followed by a further 30 minutes of breathing oxygen. During the final 10 minutes of oxygen breathing, the chamber is depressurized to ambient atmospheric pressure at a linear rate (14.2 kPa/min).
  • Arm II (control group): Patients undergo hyperbaric oxygen therapy over 90 minutes, 5 days a week, for 8 weeks for a total of 40 treatments. Oxygen at 21% is breathed for 30 minutes, followed by a 5-minute "air break" and a further 30 minutes of breathing oxygen. A further 5-minute "air break" is followed by a further 30 minutes of breathing oxygen. During the final 10 minutes of oxygen breathing, the chamber is depressurized to ambient atmospheric pressure at a linear rate (3 kPa/min).

Tissue samples from rectal biopsies may be collected and analyzed.

Patients complete questionnaires (Health Economics, Inflammatory Bowel Disease Questionnaire [IBDQ], EORTC Quality of Life [QLQ]-C30, and QLQ-CR38) at baseline and then at 3, 6, 9, and 12 months after the start of treatment.

After completion of study treatment, patients are followed within 14 days and at 10 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Past history of rectal, prostate, testicular, bladder, uterine cervix, uterine corpus, vaginal, or ovarian cancer

    • Malignant disease (T1-3, N0-1, M0)
  • No evidence of cancer recurrence
  • Gastrointestinal symptoms attributable to prior radiotherapy received at least 1 year ago, meeting 1 of the following criteria:

    • Grade 2 or higher in any Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic Scales (LENT SOMA) category
    • Grade 1 with difficult intermittent symptoms
  • Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period

PATIENT CHARACTERISTICS:

  • Must be physically and psychologically fit to undergo hyperbaric oxygen therapy
  • No claustrophobia
  • No epilepsy
  • No chronic obstructive airway disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, or untreated pneumothorax
  • No previous middle/inner ear operations (except grommets and similar procedures) and/or inability to equalize middle ear pressure
  • No contraindication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior surgery for rectal cancer
  • No prior hyperbaric oxygen therapy (excluding treatment for decompression illness)
  • No prior treatment with bleomycin
  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: NCT01087268

Locations
United Kingdom
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person    44-20-8661-3388      
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01087268     History of Changes
Other Study ID Numbers: CDR0000667367, RMH-CCR3086, EUDRACT-2008-002152-26, EU-21010, MREC-08/H0903/40
Study First Received: March 13, 2010
Last Updated: July 14, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
gastrointestinal complications
radiation toxicity
long-term effects secondary to cancer therapy in adults
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage I vaginal cancer
stage II vaginal cancer
stage III vaginal cancer
stage I malignant testicular germ cell tumor
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage I uterine sarcoma

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Vaginal Neoplasms
Neoplasms, Germ Cell and Embryonal
Pelvic Neoplasms
Sarcoma
Testicular Neoplasms
Radiation Injuries
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014