|
Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors Clinical research trials and Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors. Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors  Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
For Condition: Breast,Lymphedema,Cancer
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The goal of this study is to evaluate the effectiveness of a standardized botanical extract of Pycnogenol as a treatment for stable arm lymphedema in breast cancer survivors.
Details: Lymphedema of the arm affects the function and self-image of approximately 600,000 of the 2 million breast cancer survivors in the United States. Chronic lymphedema can lead to recurrent infections and permanent swelling, in some cases impairing function. Although various methods of massage and the use of non-elastic compression "sleeves" have been shown to decrease the severity of lymphedema, these methods of physical therapy are limited in terms of patient acceptance, compliance, and by the availability of trained therapists. There is presently no pharmacologic treatment that has proven effective in treating or preventing the development of lymphedema in women treated for breast cancer. This is a double-blind, placebo-controlled trial of an extract of the bark of the French maritime pine tree (Pycnogenol(r)) as a treatment for arm lymphedema in breast cancer survivors. Pycnogenol(r) is widely used in Europe for lymphedema of the leg and varicose veins, and is thought to act by several mechanisms including vascular permeability and vascular constriction. The development of such a therapeutic approach would therefore constitute a major breakthrough in the treatment of this common symptom of breast cancer lymphedema. Bioelectric impedance is a painless, quick, and easily-performed method of estimating the extracellular and total water volume of the body or segment, such as the arm. We will compare the correlation of both a single- and a multiple-frequency bioelectric impedance instrument in measuring change in arm volume to a standard assessment using water displacement. We expect that bioelectric impedance will prove faster and more sensitive to changes in extracellular water (lymphedema) than the water displacement method. We also propose to use a small oral dose of midazolam and single blood sampling to screen for effects of Pycnogenol(r) on the activity of the common drug metabolizing enzyme CYP3A4. For those subjects who are already receiving digoxin, we will use digoxin urine excretion to screen for effects of the botanical upon the activity of P-glycoprotein. Finally, we will continue the evaluation of a new questionnaire of lymphedema symptoms presently being tested as a tool for assessing the severity and improvement of symptoms with treatment. In summary, the successful completion of this research can be expected to provide an alternative therapy and new instruments for treating and measuring lymphedema.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Unilateral (ipsialterial to breast cancer resection side) lymphedema of the upper extremity. - Extravascular water ration of > 1.07/1 between affected vs. normal arm using multiple frequency bioelectric impedence - Patient is > 2months from last surgical or radiation treatment to the affected axilla - Renal and hepatic function: Creatinine clearance > 50ml/min, total bili <2 mg/dl, transaminases <1.5 x ULN - Patient not pregnant or breastfeeding. Use of barrier contraception if sexually active. - ECOG performance of 0-2 - Patient not allergic to pycnogenol Exclusion criteria: - Patients treated with their first course of chemotherapy or radiation - Chemotherapy or radiation to axillary lymph node will exclude patients for 8 weeks following treatment - Patients with more than one episode of arm cellulitis, venous clot, or woody fibrosis of the affected arm. Antibiotics used to treat cellulitis must be completed at least 4 weeks prior to initial screening - Patients with a defibrillator Midazolam study only: Patients requiring or benefiting from supplemental oxygen, patients allergic to cherries
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
PaulHutson, Study Chair, Associate Professor of Pharmacy
University of Wisconsin Comprehensive Cancer Center and School of Pharmacy
Madison, Wisconsin, 53706
United States
Lynn VanUmmersen 608-263-8600
Additional Information:
Study ID Numbers: R21 AT001724-01;
Study Start Date: August 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064857
Other Lymphedema Studies:
1. Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
2. A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
3. Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
4. Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
5. REST: Reducing End-of-Life Symptoms with Touch
Related Studies:
Other Lymphedema Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
|
|
|
|
|
|
|
|
