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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01087268
Other study ID # CDR0000667367
Secondary ID RMH-CCR3086EUDRA
Status Recruiting
Phase Phase 3
First received March 13, 2010
Last updated July 14, 2011
Start date January 2009

Study information

Verified date March 2010
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care


Intervention

Other:
questionnaire administration

Procedure:
gastrointestinal complications management/prevention

quality-of-life assessment


Locations

Country Name City State
United Kingdom Royal Marsden - Surrey Sutton England

Sponsors (1)

Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire No
Secondary Physician assessment of adverse effects using LENT SOMA scales of radiation injury Yes
Secondary Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38 No
Secondary Photographic images of rectal mucosa No
Secondary Physician assessment of rectal dysfunction based on the modified CTCAE grading system No
Secondary Health economics data No
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