Breast Cancer Trial, Recruiting NCT05366699 Sponsor: Stanford University Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT05366699
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 75 years old (inclusive)
  • People having surgery to remove lymph nodes from one or both armpits as part of breast cancer treatment
  • People who have no signs of cancer that has spread to distant parts of the body before surgery
  • People whose armpit lymph nodes may have tested either positive or negative for cancer
  • People who have received chemotherapy before their surgery
  • People who are willing and able to sign a written consent form
  • People who are willing and able to follow all study procedures as required

Who may not be able to join:

  • People who have lymphedema in the affected arm that was present from birth or developed on its own (not caused by surgery)
  • People who already had lymphedema in the affected arm before the lymph node removal surgery
  • People who have had radiation therapy to the armpit area before the study or surgery
  • People who have had an allergic reaction to pig-derived collagen or to a dye called ICG (indocyanine green)
  • People who are due to receive radiation therapy to the affected lymph node area within 4 weeks after surgery
  • People who have taken part in another clinical trial or received another experimental treatment within 1 month before joining this study
  • People who have another medical condition that could cause arm swelling, such as a blood clot in a vein
  • People who have another medical condition that could cause symptoms similar to lymphedema in the affected arm — such as pain, swelling, or reduced arm movement
  • People whose arm measurements at the start of the study show a significant size or fluid imbalance between arms (confirm with trial site for specific measurement thresholds)
  • People whose life expectancy is less than 2 years for any reason
  • People who are pregnant or currently breastfeeding
  • People who have had issues with alcohol or substance misuse within the 6 months before joining the study
  • People with a severe psychiatric (mental health) condition
  • People with significant or long-term kidney problems, or who require dialysis (confirm with trial site for specific test value thresholds)
  • People with significant liver problems based on blood test results at screening (confirm with trial site for specific test value thresholds)
  • People with a very low white blood cell count at screening (confirm with trial site for specific threshold)
  • People with a low haemoglobin (red blood cell) level at screening (confirm with trial site for specific threshold)
  • People whom the trial investigators believe, for any other reason, cannot fully participate in the study

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Dung Nguyen, MD, PharmD, Stanford University

Phone: 6504929239

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
10 September 2021
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Lymphatic flow pattern of whole limb; Limb Volume; Skin thickness measurements; Bioiimpedance spectroscopy; Quality of life- Limb-Lymphedema-Specific Quality of Life (LYMQOL)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov