Clinical trial NCT02266082: Persistent Post-Surgical Pain in Women With BrCA
Official title: Biobehavioral Predictors of Persistent Post-Surgical Pain in Women Undergoing Breast Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Chronic Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 5
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: Subjects participate in a brief telephone or in-person screening to determine eligibility for this study. The first in-person visit to the UF Pain Clinical Research Unit (CRC) is scheduled to coincide with a pre-operative testing or a clinic visit. During this first visit, more health information is collected related to the eligibility criteria for the study and if the visit should proceed. The in-person screening process takes about 30 minutes. The Informed Consent will be reviewed to make sure that the subjects understand everything that is involved with the study. After consent, participants are randomly assigned, like the flip of a coin, a participant ID number known only to the investigators. The participants may choose not to continue or be excluded from the study after providing the screening information. The demographic and health information provided will be shredded. These names will be kept in a locked file, however, so that the investigators don't contact them again for screening. It will be indicated, next to the name and ID number, the reason for exclusion from the study. A copy of the signed informed consent form will remain in a locked file as well for documentation purposes.

If selected for this study and agree to participate, participants will be asked to complete several tests. These tests will take around 2 hours, and will be done following the screening questions during the first visit. The first visit will take about 2 ½ hours. There will be a second and third visit (approximately 3 and 6 months later) to the UF Pain CRC for follow-up testing. Each visit will last about 2 hours. Every effort will be made to combine these visits with regular post-surgery follow-up visits to the clinic or your health care provider. Each participant's hospital medical record associated with their surgery for breast cancer will be assessed for the amount of pain they experienced following their surgery and the pain medications that they received. Information related to the type of surgery (i.e., lumpectomy, mastectomy, or reconstruction), the results of the biopsies and lymph node tests, the characteristics of the breast tumor, and information about your surgery (e.g., type of anesthesia, duration of surgery, surgical complications) will be collected.

The following will occur during all 3 visits to the center. Information about health and medications will be collected. At the 2nd and 3rd visits, any changes to health and medications since the last visit will be collected. Blood pressure, heart rate, height and weight information will be collected from all participants. Surveys about participant's thoughts and feelings about pain will be conducted.

A trained professional will draw blood (about 1-2 teaspoons) from a vein your arm. This will be used to measure laboratory values associated with inflammation in the body. Specifically, the investigators will look for biomarkers, such as chemicals and hormones that might be related to pain. They will also check the level of vitamin D in your blood. No fasting is required before these blood tests. The stored blood sample will not be labeled with the participant's name. It will be labeled only with the ID number. The samples will be stored in the University of Florida Clinical and Translational Science Biorepository.

The Investigators will instruct participants in how to use a stool specimen kit. It will be used at home and returned in the mail. A stamped envelope will be provided to the participants with each kit. This will be used to measure microbes in your gut that are associated with inflammation. The stored stool sample will not be labeled with the participant's name. It will be labeled only with the ID number. The samples will be stored in a researcher's laboratory at the University of Florida. If participants are pre-menopausal woman, a urine pregnancy test may be required.

Several tests to measure sensitivity and tolerance to pain will be performed.

1. Pressure Sensation Test - applies pressure to one knee, thigh, shoulder and arm. The pressure may be slowly increased, and participants will be asked to tell the examiner when they begin to feel discomfort or mild pain. As soon as pain is felt, the pressure will be removed.
2. Mechanical Sensation Test - a handheld probe that has a small nylon tip to tap the knee and hand. The investigator will ask participants to tell how painful this feels.
3. Heat Pain Test - Sensitivity to heat pain will be tested using a commercially available sensory testing machine that is widely used in clinical settings. The machine has a small square piece that is used to apply heat to the skin. Heat will be applied to one knee and arm. The amount of heat is controlled by a computer. The procedure can be stopped at any time so that participants do not experience pain that is unacceptable.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Intensity from baseline to 3 and 6 months post-surgery
timeFrame: Baseline, 3 months and 6 months post-operative
Secondary outcomes:
measure: Persistent Pain Intensity
timeFrame: 1 year post-operative
measure: Change from baseline in C-reactive protein
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Gut microbiome
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Vitamin D (25(OH)D)
timeFrame: Baseline and 6 months post-operative
measure: Change from baseline in Telomerase
timeFrame: Baseline and 6 months post-operative
measure: Change from baseline in Pain Interference
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Pain Catastrophizing
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Depression
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Anxiety
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Pain Qualities
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Surgical Variables
timeFrame: First 48 hours post-operative
measure: Change from baseline in Fatigue
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Sleep Disturbance
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Physical Function
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Change from baseline in Social Role Function
timeFrame: Baseline, 3 months and 6 months post-operative
measure: Acute Post-operative Pain Intensity
timeFrame: First 48 hours post-operative
measure: Pain Treatment
timeFrame: First 48 hours post-operative
measure: Change from baseline in Pain Threshold and Tolerance
timeFrame: Baseline, 3 months and 6 months post-operative
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ann L. Horgas, PhD
role: PRINCIPAL_INVESTIGATOR
References: