Persistent Post-Surgical Pain in Women With BrCA

NCT02266082 | Completed DMC

• 2 other identifiers: IRB201400616OCR15052
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity from baseline to 3 and 6 months post-surgery

  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.

  Baseline, 3 months and 6 months post-operative

Secondary Outcomes (18)

• Persistent Pain Intensity

  1 year post-operative

• Change from baseline in C-reactive protein

  Baseline, 3 months and 6 months post-operative

• Change from baseline in Gut microbiome

  Baseline, 3 months and 6 months post-operative

• Change from baseline in Vitamin D (25(OH)D)

  Baseline and 6 months post-operative

• Change from baseline in Telomerase

  Baseline and 6 months post-operative

Interventions

No intervention OTHER

There is no intervention in this study.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with early stage breast cancer, who plan to have breast surgery at UF Health/Shands Hospital in Gainesville, Florida

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A stool sample for microbiota analysis will be collected by participants at home using a standard test kit, and returned via mail. Fecal microbial DNA will be extracted from between 50-200 mg of fecal material. The 16S ribosomal gene (V4 region) of each sample will be amplified using a barcoding system to allow multiplexing with the Illumina MiSeq system. Blood samples will be collected to measure C-reactive protein (CRP) (at each visit) and telomerase/telomere and 25(OH)D level at baseline and the 6-month visit. Venous blood samples will be collected by trained staff.

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann L. Horgas, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 16, 2014
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 28, 2018

Record last verified: 2018-12

Locations

US (1)