Breast CancerNCT02266082
Persistent Post-Surgical Pain in Women With BrCA
An observational study of Breast Cancer and Chronic Pain, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Chronic Pain
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with early stage breast cancer, who plan to have breast surgery at UF Health/Shands Hospital in Gainesville, Florida
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biobehavioral Predictors of Persistent Post-Surgical Pain in Women Undergoing Breast Cancer Treatment
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.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Breast Cancer, Chronic Pain
- Being tested
- No intervention
- Medical subject headings
- Breast Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months and 6 months post-operative
Secondary outcomes (18)
Persistent Pain Intensity
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.
Measured: 1 year post-operative
Change from baseline in C-reactive protein
For the measurement of serum CRP levels, a commercially available immuno-turbidimetric assay will be used. Higher levels of CRP are associated with higher levels of systemic inflammation.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Gut microbiome
The number and type of species found in the intestinal microbiota will be assessed.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Vitamin D (25(OH)D)
Blood samples will be collected to measure total 25(OH)D level. The results are expressed in nanograms per mililiter (ng/ml), with optimal levels ranging from 30-80 ng/ml, insufficient levels ranging from 10-29 ng/ml, and severe deficiency as less than 10 ng/ml.
Measured: Baseline and 6 months post-operative
Change from baseline in Telomerase
Blood samples will be collected to measure telomerase. Telomerase activity is measured by evaluating the amount of inorganic pyrophosphate generated in Polymerase Chain Reaction (PCR) amplification of telomerase elongation product, with use of the sensitive enzymatic luminometric inorganic pyrophosphate detection assay (ELIDA). TRAP connected with ELIDA (TRAP-ELIDA) can quantitatively detect telomerase activity within linearity from 2 to 1000 cell equivalents.
Measured: Baseline and 6 months post-operative
Change from baseline in Pain Interference
Self-reported pain interference will be assessed using the NIH PROMIS-43 subscale, consisting of 6 questions. Pain interference is rated on a 5 point scale, with 1 indicating that pain does not interfere at all and 5 indicating that pain interferes with activities very much. Total scores for this subscale range from 6 to 30 (most interference).
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Pain Catastrophizing
The Pain Catastrophizing Scale will be used to measure pain cognitions. This 13 item scale is scored on a 0-5 scale, in which 0 indicates the thought does not occur and 5 indicates that the cognition occurs all the time. Total score ranges from 0-65.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Depression
Self-reported depression will be assessed using the NIH PROMIS-43 subscale, consisting of 6 questions about depression. Responses are rated on a 5 point scale, with 1 indicating the response never occurs and 5 indicating the response always occurs. Total scores for this subscale range from 6 to 30.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Anxiety
Self-reported anxiety will be assessed using the NIH PROMIS-43 subscale, consisting of 6 questions about feelings of anxiety. Responses are rated on a 5 point scale, with 1 indicating the response never occurs and 5 indicating the response always occurs. Total scores for this subscale range from 6 to 30.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Pain Qualities
Characteristics of neuropathic and nociceptive pain are assessed with the Pain Qualities Scale. This consists of 20 items that rate different pain characteristics on a 0-10 scale, with 0 indicating none of that characteristic and 10 indicating the most of that characteristic.
Measured: Baseline, 3 months and 6 months post-operative
Surgical Variables
Data about the surgical procedure will be collected from the surgical and anesthesia reports in the medical record. This will include information about surgical type (e.g., lumpectomy, mastectomy (single or double), and reconstruction. The extent of lymph node dissection (sentinel node only vs. more extensive exploration) will be recorded. The duration of surgery, type of anesthesia, amount of blood loss, and any surgical complications will also be recorded.
Measured: First 48 hours post-operative
Change from baseline in Fatigue
Self-reported fatigue will be assessed using the NIH PROMIS-43 subscale, consisting of 6 questions about feelings of fatigue. Responses are rated on a 5 point scale, with 1 indicating the feeling occurred not at all and 5 indicating the feeling occurred very much. Total scores for this subscale range from 6 to 30.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Sleep Disturbance
Self-reported sleep disturbance will be assessed using the NIH PROMIS-43 subscale, consisting of 6 questions about sleep. Overall sleep quality is rated from 1 (very poor) to 5 (very good). Responses to the remaining 5 sleep questions are rated on a 5 point scale, with 1 indicating the sleep descriptor occurred not at all and 5 indicating the sleep descriptor occurred very much. Total scores for this subscale range from 6 to 30.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Physical Function
Self-reported physical disability will be assessed using the NIH PROMIS-43 subscale consisting of 6 questions. Four questions assess ability to perform daily activities, with responses scored from 1 (without any difficulty) to 5 (unable to do). Two additional question evaluate the extent to which health limits activities, with responses from 1 (not at all) to 5 (cannot do).Total scores for this subscale range from 6 to 30.
Measured: Baseline, 3 months and 6 months post-operative
Change from baseline in Social Role Function
Self-reported ability to engage in social roles will be assessed using the NIH PROMIS-43 subscale consisting of 6 questions. Responses are scored from 1 (never has trouble/limitations) to 5 (always has trouble/limitations). Total scores for this subscale range from 6 to 30.
Measured: Baseline, 3 months and 6 months post-operative
Acute Post-operative Pain Intensity
Self-reported acute pain intensity is rated on a 10 point Numerical rating scale, with 0 indicating no pain and 10 indicating worst pain imaginable.
Measured: First 48 hours post-operative
Pain Treatment
All analgesic medications taken by participants preoperatively, during the first 48 hours post-operatively will be recorded.
Measured: First 48 hours post-operative
Change from baseline in Pain Threshold and Tolerance
Quantitative Sensory Testing (QST) will be conducted to measure heat pain (warmth, threshold, tolerance), pressure pain threshold, and punctate mechanical pain (suprathreshold ratings, temporal summation). After each test, participants will rate their pain on a 0-10 scale (0 = no pain; 10 = worst pain imaginable). Scores across multiple trials of each test will be averaged to obtain a mean score.
Measured: Baseline, 3 months and 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann L. Horgas, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266082
- Sponsor's protocol ID
- IRB201400616
- Other IDs
- OCR15052
- Status last verified
- Dec 2018
- First submitted
- 10 Oct 2014
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Predictors of Persistent Post-Surgical Pain in Women Undergoing Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT02266082
- Acronym / sponsor ID
- IRB201400616
- Conditions
- Breast Cancer, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with early stage breast cancer, who plan to have breast surgery at UF Health/Shands Hospital in Gainesville, Florida
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention in this study. | Other | – |
Primary outcome
Change in Pain Intensity from baseline to 3 and 6 months post-surgery
Time frame: Baseline, 3 months and 6 months post-operative
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.
18 secondary outcomes
Persistent Pain Intensity
Time frame: 1 year post-operative
Change from baseline in C-reactive protein
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Gut microbiome
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Vitamin D (25(OH)D)
Time frame: Baseline and 6 months post-operative
Change from baseline in Telomerase
Time frame: Baseline and 6 months post-operative
Change from baseline in Pain Interference
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Pain Catastrophizing
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Depression
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Anxiety
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Pain Qualities
Time frame: Baseline, 3 months and 6 months post-operative
Surgical Variables
Time frame: First 48 hours post-operative
Change from baseline in Fatigue
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Sleep Disturbance
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Physical Function
Time frame: Baseline, 3 months and 6 months post-operative
Change from baseline in Social Role Function
Time frame: Baseline, 3 months and 6 months post-operative
Acute Post-operative Pain Intensity
Time frame: First 48 hours post-operative
Pain Treatment
Time frame: First 48 hours post-operative
Change from baseline in Pain Threshold and Tolerance
Time frame: Baseline, 3 months and 6 months post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann L. Horgas, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chronic Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity from baseline to 3 and 6 months post-surgery (time frame: Baseline, 3 months and 6 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.