Clinical trial · Observational
Persistent Post-Surgical Pain in Women With BrCA
Biobehavioral Predictors of Persistent Post-Surgical Pain in Women Undergoing Breast Cancer Treatment
- 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)
Women with early-stage breast cancer (BrCA) are surviving longer, but many experience symptoms after curative treatments. Approximately 50% of BrCA survivors experience persistent pain post-surgery. Identifying individuals at high risk for long-term symptoms is important for restoring function and enhancing quality of life. This pilot study will investigate psychological (depression, anxiety, catastrophizing) and biological (inflammatory markers, gut microbiome, pain sensitivity) correlates of persistent post-surgical pain in women participants with early-stage BrCA. The investigators will also investigate the type of surgery that participants had and whether it is related to persistent pain. The investigators plan explore these factors over time.
Conditions
Conditions (2)
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 |
| Chronic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in Pain Intensity from baseline to 3 and 6 months post-surgery
- timeFrame
- Baseline, 3 months and 6 months post-operative
- description
- Self-reported pain intensity will be assessed using the NIH PROMIS-43 subscale for pain measurement. Pain intensity is rated on a 10 point scale, with 0 indicating no pain and 10 indicating worst pain imaginable.
Secondary outcomes (18)
- measure
- Persistent Pain Intensity
- timeFrame
- 1 year post-operative
- description
- Self-reported pain intensity will be assessed using the NIH PROMIS-43 subscale for pain measurement. Pain intensity is rated on a 10 point scale, with 0 indicating no pain and 10 indicating worst pain imaginable.
- measure
- Change from baseline in C-reactive protein
- timeFrame
- Baseline, 3 months and 6 months post-operative
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosed with breast cancer (based on biopsy) * scheduled for surgery (either lumpectomy or mastectomy, with anticipated sentinel node dissection and possible axillary lymph node dissection) * between 40 - 75 years of age. Exclusion Criteria: * history of previous cancer, chemotherapy or radiation, cardiovascular or neurological conditions, bowel surgery, or hospitalization for mental illness in past year * chronic pain conditions or daily use of opioids * pregnant or nursing * diagnosed with metastatic breast cancer after surgery and cancer staging is completed (post-lymph node dissection) * any other condition that in the opinion of the principal investigator may compromise participation in this study
References
Publications (0)
Data not yet available