Clinical Trials

[Ann]

Are interested in keeping up to date, and maybe even participating, in clinical trials to find a lymphedema cure?

If so, information about the latest US government lymphedema clinical trials, go to http://www.clinicaltrials.gov and search on lymphedema.

Ann

[Ann]

“Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection” is a randomized clinical trial sponsored by the National Cancer Institute.

The purpose of this study is to determine how well education with, or without, exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection. Participants are currently being recruited in several sites across the US. For details visit this website [http://www.clinicaltrials.gov/ct/show/NCT00376597?order=5]

Ann

[brennan102]

I work in a lymphedema treatment center that is involved in a clinical trial for UE lymphedema. It is a Phase 1 Study evaluating Bevacizumab in women with Breast Cancer Suffering from Lymphedema (AVF325s) We are looking for women interested. If interested, you can call Premiere Oncology at 480-860-5000.

[Cassie]

Hello, Andrea,

What's Bevacizumab and what're you hoping/expecting it to do for LE? How/where has it been tried before? Can you give us any more details about the study? What are the criteria for being selected as a participant? What treatment will be provided and how often? What kind of supervision? Local to Scottsdale, AZ, or national?

Thanks!
Cassie

[brennan102]

Phase 1 Study Evaluating Bevacizumab in Women with Breast Cancer Suffering from Lymphedema (AVF325s)
A Phase 1 Study Evaluating the Safety of Bevacizumab in Women with a History of Breast Cancer Suffereing from Moderate to Severe Upper Extremity Lymphedema

The purpose of this study is to determine the safety and side effects of bevacizumab in subjects with lymphedema who will initially receive the study drug alone and then in combination with standard MLD+CDT. While bevacizumab has been administered to thousands of patients with cancer, there is only limited information about the use of this study drug in subjects without active cancer. This study will help to determine the dose of the study drug to be used in future studies of subjects with lymphedema.

Bevacizumab is a recombinant humanized monoclonal antibody directed against VEGF. Bevacizumab blocks the development of new blood vessels in cancer and it is approved by the FDA for the treatment of colon cancer in combination with chemotherapy.

Eligibility*
Inclusion:
women with a history of breast cancer s/p prior surgical resection with lymphedema defined as a difference in limb volume of at least 500 ml by perometric assessment
lymphedema may be newly diagnosed or previously treated as long as it is Stage I (pitting) or II (fibrosis) at the time of study entry.
no known evidence of recurrent or active metastatic breast cancer

no chemotherapy within 6 months
normal end organ function

Exclusion:
stage III lymphedema
clinical evidence of bilateral lymphedema.
history of DVT or pulmonary embolus, MI, CVA or any other arterial thromboembolic event

problems with wound healing
anti-coagulation therapy
untreated hypertension
history of infectious complications of the involved arm or contraindication to MLD + CB
history of CHF
bleeding diathesis or coagulopathy

*Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

[Cassie]

Is the MLD+CDT free? Are wraps and garments provided? How long does tx last?

Thanks,
Cassie

[brennan102]

No, therapy needs to be covered by your insurance.