Clinical Trials and Studies

Fibralign Announces Start of European Lymphedema Prevention Clinical Study

Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema.

The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and require axillary lymph node dissection (ALND), a common surgical intervention that involves removal of compromised lymph nodes to address the spread of cancer. Peer reviewed publications have estimated that 15-25% of patients who undergo ALND develop breast cancer-related lymphedema (BCRL) due to the surgery. ALND combined with radiation therapy increases the likelihood of BCRL further up to 40%.

Led by Dr. Dimitris Dionysiou, Associate Professor in Plastic Surgery at the Aristotle University of Thessaloniki (Greece) and principal investigator, the trial aims to demonstrate the effectiveness of BioBridge as a prophylactic remedy for reducing patient risk in development of lymphedema. This off-the-shelf solution would provide a much-needed treatment that could be utilized as a simple adjunct procedure in support of current cancer interventions, significantly advancing the quality of care for patients.

About BioBridge® Collagen Matrix

BioBridge is a sterile, biocompatible and biodegradable surgical mesh that recently received CE mark for use in the surgical support of lymphatic tissue repair. The certification mark confirms that BioBridge meets the requirements of the European Medical Devices Directive, which now allows Fibralign to market the product across the European Union and other CE mark countries. BioBridge is also commercially available in the US and has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and repair soft tissue. Published preclinical studies and early clinical usage have shown that BioBridge supports the repair of damaged lymphatic vessels that causes lymphedema.

About Fibralign Corporation

Fibralign Corporation is a commercial stage healthcare company that develops and manufactures advanced therapeutic biomedical devices designed to address significant unmet medical needs by utilizing its patented Nanoweave® 3D scaffolding technology. http://www.fibralignbio.com

Contacts

In Europe: Albert Huttenga, ahuttenga@fibralignbio.com, +31 651 750 078
Greg King, CEO/President Fibralign Corp. gking@fibralignbio.com, +1 415 902 4721

For information about the US study, visit: LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) - Full Text View - ClinicalTrials.gov
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Does Immediate Lymphatic Reconstruction Decrease the Risk of LE After Axillary Lymph Node Dissection

A therapy to prevent lymphedema: Lymphedema, a buildup of lymph fluid that can cause lifelong pain, occurs in about 20 percent of breast cancer patients who have lymph nodes removed or as a result of radiation. Researchers believe immediate lymphatic reconstruction may be the best way to prevent it and are recruiting breast cancer patients up to age 75, half of whom will undergo the reconstruction surgery. “If we find [this] decreases the risk of developing lymphedema, immediate lymphatic reconstruction may become a standard of care,” says lead researcher Michelle Coriddi, MD, of Memorial Sloan Kettering Cancer Center. (NCT04241341)

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast Cancer
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Female breast cancer patients 18-75 years of age
- Patients consenting for unilateral ALND (prior history of SLNBx allowed if <6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
- Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery

Actual Study Start Date: January 22, 2020
Estimated Primary Completion Date: January 2022
Estimated Study Completion Date: January 2022

Contact: Michelle Coriddi, MD 646-608-8042 coriddim@mskcc.org
Contact: Babak Mehrara, MD 212-639-3099
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Children’s Friend Study

A Comparison of Caregivers’ Experiences in Accessing Mental Health Treatment for their Children
Are you the parent of a child with a mental health condition, a medical condition, and/or a rare disease?
Participate in a Survey:
Experiences in Accessing Mental Health Treatment.

Our names are Kim Hager, LICSW, and Maria Martinez Calderon, LMHC. We both work as outpatient therapists at Children’s Friend, Inc., an affiliate of Seven Hills Foundation, in Worcester, MA. We are interested in studying the experiences in and barriers to accessing mental health services for families. For the purpose of our study, we intend to compare three groups – caregivers of children with one or more mental health conditions, caregivers of children with mental health conditions and common medical conditions, and caregivers of children with mental health conditions and rare disease. Caregivers include biological parents, adoptive parents, foster parents, step-parents, and kinship homes with children under the age of 18. The survey is nationwide and open to families who live anywhere within the United States. The hope is the survey results will assist mental health providers in tailoring services to meet families’ needs.

You are welcome to contact us at Children’s Friend, Inc. at 508-753-5425 with further questions.

Take the survey in English.
Take the survey in Spanish.
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The International Lymphatic Disease and Lymphedema Patient Registry & Biorepository

We invite you to participate in this highly significant development for the patient community. An international patient registry paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic diseases. We encourage all patients to participate in this important initiative.
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Stanford Study On Response To Drug Therapy For Lymphedema

Researchers at Stanford University in Stanford, CA are conducting a study on the response to drug therapy for lymphedema. You may be eligible for this study if you have chronic lymphedema and are eligible for the drug therapy. Participants will not be paid for their participation. The study length is approximately 6 months.

All prospective study subjects who are not current patients of the lymphedema treatment clinic at the Stanford Center for Lymphatic and Venous Disorders must first be evaluated by Dr. Rockson to assess if they are appropriate candidates for the study. There are two study appointments after the initial clinical evaluation. If interested, or for more information, please contact:

Leslie Roche RN, Clinical Research Coordinator Email address: lesroche@stanford.edu

For general information about participant rights, contact 1-866-680-2906.
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Recovery & Rejuvenation Project

This is a partnership between the Recovery & Rejuvenation project at Arizona State University, the Mayo Clinic, the University of Arizona, and community organizations in the Phoenix metropolitan area. The purpose of this project is to explore ways of helping women recover from breast cancer. It is very common for breast cancer survivors to report low energy, lack of focus, poor memory or trouble sleeping for months and even years after treatment. The goal of this project is to explore ways to improve energy levels through classes designed to help participants find their way back to wellness.

The project focus is on women who:
o Have been diagnosed with Stage 0 to III breast cancer
o Are 6 months to 10 years past primary treatment
o Age: 45-75

Eligibility process:
o 1st step: 10-15 minute pre-screen that goes over health history and diagnosis.
o 2nd step: if eligible after the pre-screen, a 10-15 minute in-person meeting will be scheduled to complete the process and an informed consent will be obtained.

Classes:
o Women will be randomly assigned to one of three classes. Two of the classes will focus on gentle movement. The third class will have a book club format and will focus on readings that are designed to educate and support women through their recovery.
o Classes will be scheduled for one hour each week, for a total of 8 consecutive weeks. All class materials will be provided at the first class. The classes will take place at various community site locations throughout the Phoenix Metropolitan area.
o Participants will take part in three health assessments: before and after the eight class sessions, and 24 weeks after classes end. Blood and saliva samples will be collected as well as questionnaires related to diet, sleep and activity level.

Benefits:
o Participating women may improve levels of vitality, physical activity, sleep quality, mood, cognitive function, peripheral neuropathy, and inflammation.

This research project is supported by the National Cancer Institute of the National Institutes of Health under Award Number R01CA182901.

If you have any questions you can contact us by phone at (602) 496-2329 or by email at recovery.rejuvenation@asu.edu.
BIDMC Acupuncture for Breast Cancer Related Lymphedema Study

Researchers at Beth Israel Deaconess Medical Center in Boston, MA are conducting a study to demonstrate the feasibility and effectiveness of acupuncture for patients with breast cancer related lymphedema.

You may be eligible for this study if you have a single arm affected by lymphedema following breast cancer treatment.

Participants will be paid $50 for their time and will receive acupuncture treatments free of charge.

The study length is 6 weeks.

All prospective study subjects who are not current patients of the lymphedema treatment clinic at BIDMC must first be evaluated by Dr. Singhal to assess if they are appropriate candidates for the study (a comprehensive lymphedema evaluation) and then have clinical measurements taken by a certified lymphedema therapist. (These two appointments are outside of the study).

There are a total of 12 acupuncture sessions which take place over a 6-week period. Acupuncture sessions generally begin 1-2 weeks after a patient has had their baseline evaluation (lab work and clinical measurements). Clinical measurements are repeated at week 3 (midpoint) of the study. At the end of the study (week 6), participants have clinical measurements and bloodwork taken.

There are two study groups (all patients are offered 12 acupuncture sessions regardless of initial group assigned!)—one group receives 12 acupuncture sessions right away during this 6 week period (after baseline evaluation), and the other group is monitored clinically for 6-weeks, but then receives their 12 acupuncture treatments after that time period.

All parking-related costs are reimbursed by the study.

Please contact the study team to find out more or to see if you are eligible:

Dhruv Singhal, MD
Email address: lymphaticsurgery@bidmc.harvard.edu
Phone Number: 617-632-7827
Systemic Therapy to Treat Lymphatic Malformations

Clinical Trial at Stanford School of Medicine:

Dr. Joyce Teng, MD, PhD at Stanford University School of Medicine, CA is conducting a clinical trial on the use of Sildenafil treatment for patients ages 6 months - 10 years of age with Lymphatic Malformations (LM).

Participation involves visits to Stanford, as well as at local sub-sites being conducted in Chicago, IL, and Denver, Colorado. Duration is 20 - 52 weeks. There is no compensation for this study, but all travel is covered by Stanford. A separate study is also being conducted, which involves genetic testing of patients with lymphatic malformations.

To find out more information or to see if your child qualifies, please contact Elidia Tafoya, MPH, study coordinator, at 650-724-1982 or by email at etafoya@stanford.edu. To view clinical study flyer, click here.
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University of Missouri-Columbia (MU) lymphedema study for breast cancer survivors

A new study is available through the University of Missouri-Columbia (MU) for breast cancer survivors who have been diagnosed with lymphedema. It uses interactive theatre and printed information compared to printed information alone to test whether an interactive approach is more effective than printed information alone in helping women stick to their lymphedema self-management regimens.

For more information and/or scheduling a study appointment, please contact Pamela Ostby, PhD(c), RN, OCN® at 314/255-6677 or you can email leresearch@missouri.edu.

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AMERICA’S CLINICAL RESEARCH HOSPITAL

The National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, is the nation’s largest hospital devoted entirely to clinical research. Learn More >
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