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A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients with Chronic Pain

Researcher
N. Lynn Henry, MD, PhD; Anna Beck, MD; Adam Cohen, MD; Saundra Buys, MD; John Ward, MD; Hung Khong, MD; Elizabeth Prystas, MD
Summary

The purpose of this study is to better understand why some breast cancer survivors who have chronic pain and are treated with duloxetine will have their level of pain improve, while others will not. Women with breast cancer who have chronic pain will be asked to enroll. Participants will be treated with duloxetine for 7 weeks in order to determine how the medication affects both their level of pain and their sensitivity to pain. The research team hopes to understand more about why breast cancer survivors develop pain after their diagnosis and treatment, and why some people respond better to this type of treatment. The research team needs 56 women to participate in this study.  

Who can participate?

You can sign up for the study “A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients with Chronic Pain (IRB 94979)” if you meet ALL of these MAIN criteria:

  • You are female and 25 years of age or older
  • You were diagnosed with breast cancer (Stage 0 – III) in the past 12 years
  • You have chronic pain that developed or worsened since your breast cancer diagnosis
  • Your chronic pain has been present for at least 3 months
  • You completed all indicated surgery, chemotherapy and/or radiation therapy at least 12 weeks prior to enrollment [it is OK if you are currently taking endocrine therapy or trastuzumab (Herceptin)]
  • You do NOT have thumbnail abnormalities that would alter pain perception (e.g., severe numbness, damage to thumbnail, artificial nails)
  • You are NOT pregnant or breastfeeding
  • You are NOT currently taking anticoagulants (e.g., Coumadin, Lovenox)
  • You have NOT previously taken duloxetine (Cymbalta) or milnacipran (Savella) for any reason
  • You are willing and able to travel (at your own expense) to the clinic in Salt Lake City, UT

After you RSVP, the research team will contact you to ask additional questions to be sure that the study is a good fit for you. 

What does participation involve?

If you sign up for the study “A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients with Chronic Pain (IRB 94979),” the research team will contact you to confirm that you are potentially eligible and interested in being screened for participation. The following is a summary of what you would do during the study. 

The study is divided into three parts: 

Screening: 
First, you will be asked to attend a Screening Visit at the Huntsman Cancer Institute in Salt Lake City, UT and do the following: 

  • Sign the informed consent document. 
  • Have your vital signs checked. 
  • Provide a list of the medications you are currently taking. 
  • Confirm your answers to the other eligibility questions. 

The research team will also request permission to collect information from your medical records about the treatments you have had for breast cancer. 

If you are currently taking an antidepressant medication for any reason, you will be asked to gradually discontinue the medication over 1-4 weeks before you can start participation in the study. 

Baseline: 
The Baseline Visit will take place before you start taking the study medication. 

  • If you are not taking any antidepressant medications at the time of the Screening Visit that you must stop taking before participation, you can do the Baseline Visit at the time of the Screening Visit. 
  • If you have to discontinue a medication, you will be asked to return to the Huntsman Cancer Institute for the Baseline Visit once you have stopped the medication. 

At the Baseline Visit you will: 

  • Have your vital signs checked (if a different day from the Screening Visit). 
  • Complete a set of questionnaires to evaluate pain and other symptoms you may be having, including depression, anxiety, stress, fatigue, and difficulty sleeping. 
  • Test how sensitive you are to pain by applying pressure to your thumbnails (you will feel different amounts of pressure on your thumbnails, from light to heavy, which may sometimes be painful). 

Treatment: 
You will then be treated with the study medication (duloxetine). You will take the medication at home and be asked to do the following: 

  • Complete a daily medication log
  • Take the medication as instructed for 5 weeks and then return to the Huntsman Cancer Institute to complete questionnaires, an assessment of your vital signs, and pain testing.

Following your visit you will be given 2 additional weeks of duloxetine and will be called by the research team 1-2 weeks later to find out how you are doing.

  BCHX03 WMNONL TPEFFX  RECREG

Where?
Huntsman Cancer Institute at the University of Utah, Salt Lake City