Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT01087268
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01087268
Study Brief:
Protocol Section:
NCT01087268