Track topics on Twitter Track topics that are important to you
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.
- 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.
Allocation: Randomized, Control: Active Control, Masking: Double-Blind, Primary Purpose: Supportive Care
questionnaire administration, gastrointestinal complications management/prevention, quality-of-life assessment
Royal Marsden - Surrey
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:15:12-0400
The purpose of the present study is to advance in the knowledge of quality of life in patients with ILD by translating a ILD quality of life questionnaire. There are no specific tools val...
Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concer...
RATIONALE: A step-by-step procedure may help health care practitioners diagnose and treat cancer patients with bowel injury symptoms caused by radiation therapy. PURPOSE: This randomized ...
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuva...
This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common pr...
Findings regarding changes in the quality of life (QOL) of patients with gastrointestinal cancers (GI) undergoing chemotherapy (CTX) are inconclusive. Purpose was to evaluate for changes in QOL scores...
A better understanding of coeliac disease can be achieved by assessing health-related quality of life alongside clinical factors. Existing patient-reported outcome measures (PROMs) evaluating quality ...
To determine the applicability of the generic instrument Pediatric Quality of Life Inventory (PedsQL 4.0) to assess health-related quality of life of asthmatic children compared to the specific instru...
The objective for this study was to combine drinking characteristics and two subjective measures, drinker identity and alcohol-related quality of life, i.e., negative impact of alcohol on quality of l...
Head and neck cancer affects esthetic and anatomical parameters, causing pain and functional impotence, affecting vital functions such as eating and breathing, hampering the quality of life of patient...
A quality-of-life scale developed in the United States in 1972 as a measure of health status or dysfunction generated by a disease. It is a behaviorally based questionnaire for patients and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like. It measures the patient's perceived health status and is sensitive enough to detect changes or differences in health status occurring over time or between groups. (From Medical Care, vol.xix, no.8, August 1981, p.787-805)
The application of industrial management practice to systematically maintain and improve organization-wide performance. Effectiveness and success are determined and assessed by quantitative quality measures.
Individual's ability to manage the symptoms, treatment, physical and psychosocial consequences and lifestyle changes inherent in living with a chronic condition. Efficacious self-management encompasses ability to monitor one's condition and to effect the cognitive, behavioral, and emotional responses necessary to maintain a satisfactory quality of life.
Participation of employees with management as a labor-management team, in decisions pertaining to the operational activities of the organization or industry.
Measures aimed at providing appropriate supportive and rehabilitative services to minimize morbidity and maximize quality of life after a long-term disease or injury is present.
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...