Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old.
• People who are breast cancer survivors and have been free of cancer and cancer treatment for at least 3 years (continuing hormone/endocrine therapy is still allowed).
• People who have arm swelling (lymphedema) caused by breast cancer treatment.
• People whose arm swelling affects one arm and does not fully go away with elevation or compression.
• People with Stage I or Stage II lymphedema, based on international lymphedema staging standards (confirm with trial site).
• People who have completed a full course of a standard lymphedema therapy program (called Complete Decongestive Therapy) at least 12 weeks before the screening visit, including wearing compression garments consistently for at least 12 weeks without changing the routine.
• People who are well enough to safely have general anaesthesia and undergo the surgical procedure involved in this trial.
• People with a reasonable general level of physical functioning, assessed using a standard scale (confirm with trial site).
• People with a life expectancy of more than 2 years.
• People whose affected arm and unaffected arm differ in volume by at least 10%.
• People who show abnormal fluid measurement results on a bioimpedance test, where this test can be done (confirm with trial site).
• People who are willing and able to consistently wear compression garments throughout the entire study, except for the first 3 weeks after surgery.
• People who are willing to follow the recommended self-care routine throughout the study, keeping it consistent from the start.
• People who are willing and able to attend all study visits, including skin biopsy measurements and imaging before and after surgery.
• People who are willing and able to understand and sign a written consent form.

Who may not be able to join:

• People who cannot safely undergo general anaesthesia or the surgical care required for this procedure.
• People whose arm swelling is caused by vein problems rather than lymphedema.
• People who started lymphedema therapy (CDT) less than 12 weeks before screening.
• People currently receiving chemotherapy or radiation therapy.
• People with evidence of cancer, or a history of cancer in the past 3 years (with the exception of certain treated skin cancers or treated cervical cancer in situ — confirm with trial site).
• People with another medical condition that could cause or contribute to arm swelling, such as a blood clot in a vein or heart failure.
• People with another medical condition that could cause symptoms similar to lymphedema in the affected arm, such as pain, swelling, or reduced movement.
• People with a history of a blood clotting disorder.
• People with a long-term or ongoing infection in the affected arm.
• People who have had an infection in the affected arm within 1 month before screening.
• People currently taking part in another clinical trial involving an experimental drug or treatment within 1 month before screening, or longer depending on the drug involved.
• People with significant kidney problems (confirm with trial site for specific test values).
• People with significant liver problems (confirm with trial site for specific test values).
• People with a low white blood cell count below a certain level at screening (confirm with trial site).
• People with a low haemoglobin (red blood cell) level below a certain level at screening (confirm with trial site).
• People with a Body Mass Index (BMI) above 35.
• People with a known sensitivity or allergy to pork-derived products.
• People with a severe allergic reaction (anaphylaxis) to iodine.
• People who are pregnant or breastfeeding.
• People with a history of alcohol or drug misuse within 6 months before screening.
• People the trial doctors determine, for any other reason, are not suitable for full participation in the study.

Important: Always verify eligibility with the trial site directly before applying.