Clinical trial · Interventional
Impact of Osteopathic Manipulative Medicine on Sentinal Lymph Node Biopsy Dye and Tracer Uptake
The Impact of Osteopathic Manipulative Medicine on Radiotracer and Isosulfan Blue Dye Uptake During Breast Conserving Surgery and Sentinel Lymph Node Biopsy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OMM prior to SLNB | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Massage
- description
- 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.
- type
- EXPERIMENTAL
- label
- OMM + Massage
- description
- 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.
- interventionNames
- Procedure: OMM prior to SLNB
Primary outcomes (1)
- measure
- Percentage of isosulfan blue dye uptake in the lymph nodes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * First time breast cancer patients (female only) undergoing breast conserving surgery (lumpectomy or partial mastectomy) and sentinel lymph node biopsy. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available