|
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer Clinical research trials and Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer. Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "H" Clinical Trials Conditions > Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
For Condition: stage 1 breast cancer,Radiation Fibrosis,perioperative/postoperative complications,Lymphedema,stage 2 breast cancer,stage 3A breast cancer
Status: Recruiting
Sponsor(s): Royal Marsden Hospital ,
Synopsis: RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for breast cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of hyperbaric oxygen therapy with that of standard therapy in treating chronic arm lymphedema in women who have undergone radiation therapy for early breast cancer.
Details: OBJECTIVES: Primary - Compare the efficacy of hyperbaric oxygen (HBO) therapy vs standard management, in terms of reduction of lymphedema, in women with chronic arm lymphedema after radiotherapy for early breast cancer. Secondary - Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO therapy. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo hyperbaric oxygen therapy over 90 minutes 5 days a week for 6 weeks. - Arm II: Patients receive standard management. Patients are followed at 3, 6, 9, 12, and 15 months. PROJECTED ACCRUAL: A total of 63 patients (42 for arm I and 21 for arm II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - History of early breast cancer (T1-3, N0-1, M0) - Prior breast surgery with or without axillary dissection - Prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago - Arm lymphedema - At least 15% increase in arm volume - No evidence of cancer recurrence - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Over 18 Sex - Female Menopausal status - Not specified Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Pulmonary - No chronic obstructive airway disease - No bullous lung disease - No acute or chronic pulmonary infection - No uncontrolled asthma - No untreated pneumothorax Other - Physically and psychologically fit for HBO therapy - No claustrophobia - No epilepsy - No eustachian tube dysfunction - No recurrent attacks of vertigo - No contraindication to MRI (e.g., intracranial ferrous material) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics - No prior ear operations Other - No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LoneGothard, Study Chair, Royal Marsden Hospital
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting John Yarnold 44-20-8661-3388
Additional Information:
Study ID Numbers: CDR0000349496; RMNHS-HOT,EU-20337
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077090
Other Stage 3a Breast Cancer Studies:
1. Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
2. Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
3. Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
4. Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
5. Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other England Clinical Trials
Other Sutton Clinical Trials
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
|
|
|
|
|
|
|
|