Clinical Trials and Studies

Stanford Arm Lymphedema Drug Study (HEAL)

Researchers at Stanford University in Stanford, CA are conducting a study on the response to a drug for lymphedema (NCT05203835). You may be eligible for this study if you have single arm lymphedema and qualify for the drug therapy. Participants will not be paid for their participation. The enrollment duration is approximately 9 months.

Key Inclusion Criteria:
1. Single arm lymphedema
2. Lymphedema of ≥ 6 months duration
3. Male or female
4. Ages 18-75

The Stanford Center for Lymphatic and Venous Disorders evaluate all prospective participants to assess if they are appropriate candidates for the study. There are four research-related appointments.

For more information, please contact:
George Varghese, Clinical Research Coordinator
Email address: georgemv@stanford.edu

For general information about participant rights, contact 1-866-680-2906.
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Clinical Research Study Optimizing MLD

Physical and Occupational therapists, plastic and vascular surgeons, and lymphatic researchers may all teach Manual Lymphatic Drainage (MLD) a little differently. Providers from UCHealth and the University of Colorado teamed up to improve and learn to teach MLD the same way. This is to reduce the lymphedema burden on patients.

For more information, contact NargisKalia, MPH at 303-724-7361 or nargis.kalia@cuanschutz.edu
The World’s First Implantable Device for Lymphedema Treatment

The study consists in a first-in-man clinical investigation for LymphoPilot, an investigational implantable medical device. LymphoPilot is composed of an implanted part and an external wearable device. The implanted part (pump, drainage catheter and output catheter), is implanted in the subcutaneous tissue of the arm and drains excess fluids to the supraclavicular subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The external part consists in a wearable controller used to activate the implanted pump.
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Lymphedema Patient Survey

Do you have lymphedema? Please respond to this anonymous on-line survey: Lymphedema Patient Survey

It will take only 3 minutes, but your participation is extremely important! The data that we collect will help us to inform doctors, hospitals, third party payers and the government about the lymphedema patient experience.
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Lymphatic Anatomy and Function Study - Breast Cancer Survivors

Researchers from the Boston Lymphatic Center at Beth Israel Deaconess Medical Center are conducting a study to identify normal variation in lymphatic anatomy in the upper extremities of female breast cancer survivors. For more information, download the flyer below.

Flyer_Breast_Cancer_Survivors.pdf
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Lymphatic Anatomy and Function Study - Healthy Volunteers

Researchers from the Boston Lymphatic Center at Beth Israel Deaconess Medical Center are conducting a study to identify normal variation in lymphatic anatomy in the upper extremities of healthy volunteers. For more information, download the flyer below.

Flyer_Healthy_Volunteers.pdf
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PureTech Health Study of Investigational Treatment for Lymphedema

PureTech Health is conducting a study to evaluate its investigational product candidate, LYT-100 (deupirfenidone), for the potential treatment of breast cancer related lymphedema. PureTech is committed to developing medicines for devastating diseases, and the company believes that LYT-100 has the potential to treat lymphedema.

Men and women between the ages of 18 and 80 with documented breast cancer-related lymphedema may be eligible to participate in this study.

Key Inclusion criteria:
1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
2. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy [FNA]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study.
3. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening.
4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study.
5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline.
6. Documented evidence of Stage 1 or 2 single arm lymphedema.

Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022

Contacts:
Christopher Korth: +1 617-226-4813 ckorth@puretechhealth.com
Michael Chen: +1 617-226-4813 mc@puretechhealth.com
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Analysis of Role Changes for Women with Breast Cancer Related Lymphedema to Return to Work

IS THIS STUDY RIGHT FOR YOU?

❖ Have you been diagnosed with breast cancer related lymphedema?
❖ Do you experience difficulty with everyday tasks due to symptoms associated with breast cancer related lymphedema (BCRL)?
❖ Are you limited with your ability to perform successfully at work due to symptoms?
❖ Do you currently receive rehabilitation services for lymphedema management secondary to breast cancer?
❖ Inclusion criteria: female between the ages of 18-65, diagnosed with breast cancer or breast cancer related lymphedema.
❖ Exclusion criteria: outside of the age parameters listed in the inclusion, not a female, does not have a diagnosis of breast cancer or breast cancer related lymphedema.

WHAT WOULD YOU HAVE TO DO?

● Participate in a short 15 question internet survey, answering the questions to the best of your ability.
● The survey will be anonymized, and no collection of any identifiable information will occur to avoid any violation of protection to the participants.
● Private message the study investigator on the Facebook support group to participate in the study.

This study is voluntary and you may withdraw at any time. Your information will be kept confidential and no information that could potentially identify you will be published.

If you would like to receive more information regarding the study, please contact the investigator for this study:

Soraya Martinez, Occupational Therapy Doctorate Student at the University of St. Augustine for Health Sciences, Email: s.martinez@usa.edu; Phone number: 407-535-7749
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An update on the priorities for women living with breast cancer related lymphoedema

An update on the priorities for women living with breast cancer related lymphoedema and the relationship with severity
The University of Sydney is conducting an online survey looking at the needs of women living with breast cancer-related lymphoedema. Participation in this research study is voluntary. The survey will take approximately 20 minutes to complete.

Women who have been diagnosed with breast cancer and as a result of treatment and have experienced upper limb swelling (lymphoedema). Women should have completed treatment for their breast cancer (except for hormone treatment) at least 6 months ago and have experienced upper limb lymphoedema for more than 12 months

A survey will be completed online which will investigate your needs arising from living with upper limb lymphoedema including:
· The severity of your lymphoedema.
· How lymphoedema has impacted your daily and working life.

If you have breast cancer related lymphoedema with access to the internet using a computer, laptop, Ipad or smart phone we would love to hear from you!

To participate in the survey, click here.

If you have questions or would like more information about participating, please contact us at jfre8103@uni.sydney.edu.au.
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International research study looking at psychological well-being in lipoedema

The purpose of this project is to understand the experiences of women with lipoedema and its impact on their well-being. This project is being undertaken by Chantelle Clarke in fulfilment of the Doctor of Philosophy program within the School of Health, Medical and Applied Sciences at CQUniversity Australia under the supervision of Associate Professor Talitha Best (CQUniversity) and Dr. James Kirby (University of Queensland).

Women over 18 years of age with lipoedema (suspected or diagnosed) are eligible to participate in this study. Participation in this project involves the completion of an online survey which will take approximately 30-45 minutes to complete.

To contact the researchers for further information about this project, email the principle investigator Chantelle Clarke at c.clarke2@cqu.edu.au

For more information and the survey link, click here.
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