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

Primary Purpose

Bladder Cancer, Cervical Cancer, Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
questionnaire administration
gastrointestinal complications management/prevention
quality-of-life assessment
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring 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, stage II uterine sarcoma, stage III uterine sarcoma, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IA ovarian germ cell tumor, stage IB ovarian germ cell tumor, stage IC ovarian germ cell tumor, stage IIA ovarian germ cell tumor, stage IIB ovarian germ cell tumor, stage IIC ovarian germ cell tumor, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Marsden - SurreyRecruiting

Outcomes

Primary Outcome Measures

Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire

Secondary Outcome Measures

Physician assessment of adverse effects using LENT SOMA scales of radiation injury
Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38
Photographic images of rectal mucosa
Physician assessment of rectal dysfunction based on the modified CTCAE grading system
Health economics data

Full Information

First Posted
March 13, 2010
Last Updated
July 14, 2011
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01087268
Brief Title
Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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, stage II uterine sarcoma, stage III uterine sarcoma, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IA ovarian germ cell tumor, stage IB ovarian germ cell tumor, stage IC ovarian germ cell tumor, stage IIA ovarian germ cell tumor, stage IIB ovarian germ cell tumor, stage IIC ovarian germ cell tumor, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
gastrointestinal complications management/prevention
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire
Secondary Outcome Measure Information:
Title
Physician assessment of adverse effects using LENT SOMA scales of radiation injury
Title
Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38
Title
Photographic images of rectal mucosa
Title
Physician assessment of rectal dysfunction based on the modified CTCAE grading system
Title
Health economics data

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Yarnold, MD, FRCR
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-8661-3388

12. IPD Sharing Statement

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

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