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Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer Clinical research trials and Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer. Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer  Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
For Condition: Lymphedema,Quality of Life,stage 1 breast cancer,stage 2 breast cancer,stage 3A breast cancer,Male Breast Cancer
Status: No longer recruiting
Sponsor(s): Royal Marsden Hospital ,
Synopsis: RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women who have received radiation therapy for breast cancer. PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation therapy for breast cancer.
Details: OBJECTIVES: I. Determine the effects of vitamin E and pentoxifylline on lymphedema in patients previously treated with radiotherapy for breast cancer. II. Compare the normal tissue injury and quality of life in patients treated with this regimen vs placebo. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vitamin E and oral pentoxifylline twice daily for 6 months. Arm II: Patients receive oral placebo twice daily for 6 months. Quality of life is assessed at baseline and at 3, 6, 9, and 12 months. Patients are followed at 6 and 12 months. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Prior diagnosis of breast cancer; T1-3, N0-1, M0 - Prior radiotherapy to breast/chest wall plus axilla and/or supraclavicular fossa - At least 2 years since prior radiotherapy - No disease recurrence - Arm lymphedema due to prior radiotherapy; Reduced shoulder movement, induration in breast/chest wall, radiation-induced brachial plexopathy, symptomatic lung fibrosis, or non-healing wounds (including fractures) allowed as evidence of disability in addition to arm lymphedema - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: No concurrent insulin - Radiotherapy: See Disease Characteristics - Surgery: No prior axillary surgery; Lower axillary sampling allowed - Other: At least 3 months since prior daily vitamin E supplementation of more than 30 mg/day; No prior pentoxifylline after radiotherapy; No concurrent ketorolac or vitamin K; No other concurrent vitamin E supplementation --Patient Characteristics-- - Age: Not specified - Sex: Female or male - Menopausal status: Not specified - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: No liver failure - Renal: No renal failure - Cardiovascular: No ischemic heart disease; No hypertension; No hypotension; No acute myocardial infarction; No prior cerebral hemorrhage; No prior retinal hemorrhage - Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception; No allergy to coconut oil
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnYarnold, Study Chair, Royal Marsden Hospital
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068794; EU-20050,RM-1597
Study Start Date: January 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022204
Other Stage 3a Breast Cancer Studies:
1. Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
2. Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
3. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
4. Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
5. Biological Therapy in Treating Patients With Advanced Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other England Clinical Trials
Other Sutton Clinical Trials
Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
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