Clinical trial NCT01087268: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-03-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire
Secondary outcomes:
measure: Physician assessment of adverse effects using LENT SOMA scales of radiation injury
measure: Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38
measure: Photographic images of rectal mucosa
measure: Physician assessment of rectal dysfunction based on the modified CTCAE grading system
measure: Health economics data
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: John R. Yarnold, MD, FRCR
role: PRINCIPAL_INVESTIGATOR
References: