Impact of Osteopathic Manipulative Medicine on Sentinal Lymph Node Biopsy Dye and Tracer Uptake

NCT07269860 | Completed DMC

• 1 other identifier: STUDY00004477
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if osteopathic manipulative medicine (OMM) will allow for more uptake of isosulfan blue dye and radiotracers used in sentinal lymph node biopsy (SLNB) compared to massage alone. SLNB is used to characterize the stage and spread of cancer cells in breast cancer patients. The main questions it aims to answer is: \- Does OMM + massage allow for greater uptake of isosulfan blue dye and radiotracer in the lymph nodes compared to current standard of practice of breast massage after isosulfan blue dye and radiotracer injection. Researchers will compare OMM + massage to current standard of practice of breast massage. Randomization: Patients will be randomized prior to surgical intervention as to which arm of the study they will be assigned to: Massage (current standard) vs OMM + Massage Massage: 9 minutes of circular massage over the nipple areolar complex to disperse isosulfan blue dye and radiotracer that were injected into the breast. Massage following injection is standard of care. OMM+ Massage: 5 minutes of massage as above and then will perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care.

Conditions

Breast Cancer

Keywords

Osteopathic Manipulative Medicine; Sentinal lymph node biopsy

Outcome Measures

Primary Outcomes (1)

• Percentage of isosulfan blue dye uptake in the lymph nodes

  In order to quantify the amount of blue dye uptake in a node, each node removed during the procedure will be categorized under blue or not blue. The percentage of blue dye uptake is determined visually by the operating surgeon. All surgeons were trained on how to identify these percentages. A node is labeled as 25% blue if it had a blue channel and/or minimal blue coloration of the node, 50% blue if it is a moderately/partially blue node, 75% blue if it was a mostly blue node, and 100% blue if it was a completely blue node.

  Through study completion, 4 months

Secondary Outcomes (1)

• Target value of neoprobe that tell how much radiotracer makes it to the lymph nodes

  Through study completion, 4 months

Study Arms (2)

Massage

NO INTERVENTION

Patients will receive the standard of care practice for SLNB of 9 minutes of circular massage over the nipple areolar complex to disperse isosulfan blue dye and radiotracer that were injected into the breast.

OMM + Massage

EXPERIMENTAL

5 min of massage plus perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care.

Procedure: OMM prior to SLNB

Interventions

OMM prior to SLNB PROCEDURE

Perform osteopathic techniques including 1 minute of each of the following: opening the thoracic inlet, pectoral traction, and axillary pump. Thoracic pump will be done for 2 minutes. Isosulfan blue dye and radiotracer will then be injected followed by massage as done in the current standard of practice. The injection and massage are performed as per standard of care.

OMM + Massage

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: First time breast cancer patients (female only) undergoing breast conserving surgery (lumpectomy or partial mastectomy) and sentinel lymph node biopsy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First time breast cancer patients (female only) undergoing breast conserving surgery (lumpectomy or partial mastectomy) and sentinel lymph node biopsy.

You may not qualify if:

• Previous breast cancer
• previous axillary surgery
• previous chest wall or axillary radiation
• previous breast surgery
• known axillary disease
• patients undergoing total mastectomies
• Contraindications to OMM include inability to access the axilla due to range of motion, previous shoulder injury or shoulder surgery on the treatment side, fractures or metastatic lesions to the bones on the treatment side, open wounds over the treatment area or underlying abscess/infection, pacemaker on the side of treatment, subclavian vein central line or port.

Sponsors & Collaborators

• University of Arizona: lead
• Tucson Osteopathic Medical Foundation: collaborator

Study Sites (1)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ivy Stejskal, DO

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio to receive standard of care or intervention.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: July 9, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)