Bladder CancerPhase 3NCT01087268
Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
A Phase 3 study testing questionnaire administration, gastrointestinal complications management/prevention and quality-of-life assessment in people with Bladder Cancer and Cervical Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Cervical Cancer, Colorectal Cancer
- What is being tested?
- questionnaire administration, gastrointestinal complications management/prevention and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Contact Person, 44-20-8661-3388
About this study
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)
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.
Read the 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.
- Conditions
- Bladder Cancer, Cervical Cancer, Colorectal Cancer, Endometrial Cancer, Gastrointestinal Complications, Long-term Effects Secondary to Cancer Therapy in Adults
- Being tested
- questionnaire administration, gastrointestinal complications management/prevention, quality-of-life assessment
- 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
- Medical subject headings
- Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Radiation Injuries, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
gastrointestinal complications management/preventionProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- John R. Yarnold, MD, FRCR, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087268
- Sponsor's protocol ID
- CDR0000667367
- Other IDs
- RMH-CCR3086, EUDRACT-2008-002152-26, EU-21010, MREC-08/H0903/40
- Status last verified
- Mar 2010
- First submitted
- 13 Mar 2010
- Last updated
- 15 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01087268
- Acronym / sponsor ID
- CDR0000667367
- Conditions
- Bladder Cancer, Cervical Cancer, Colorectal Cancer, Endometrial Cancer, Gastrointestinal Complications, Long-term Effects Secondary to Cancer Therapy in Adults
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | – |
| gastrointestinal complications management/prevention | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R. Yarnold, MD, FRCR principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing questionnaire administration, gastrointestinal complications management/prevention and quality-of-life assessment in people with Bladder Cancer and Cervical Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2011.