Pain Clinical Trial
Official title:
A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain
Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy,
and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have
reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin
norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety,
fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.
Pilot data suggest that duloxetine is effective in management of endocrine therapy-associated
musculoskeletal pain, and a randomized placebo controlled trial of duloxetine has
demonstrated efficacy for treatment of chemotherapy-induced neuropathic pain. In this
mechanistic study of duloxetine, we will investigate the change in pain sensitivity with
treatment in order to evaluate both why duloxetine is effective for management of pain for
some patients, as well as predictors of who is likely to benefit from duloxetine. A total of
84 women with early stage breast cancer who have chronic pain following treatment, as well as
48 women who are pain free, will be enrolled. All subjects will undergo assessment of pain
sensitivity and complete questionnaires. Subjects with pain will be treated with duloxetine
for a total of 7 weeks, with pain sensitivity assessments before treatment and after 4 weeks
of full-dose treatment.
Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy,
and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have
reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin
norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety,
fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.
Data from a randomized, placebo-controlled clinical trial of duloxetine demonstrated that it
is effective in management of both aromatase inhibitor-associated musculoskeletal pain and
chemotherapy-induced neuropathic pain. In this mechanistic study, we investigated the change
in pain sensitivity with treatment in order to evaluate both why duloxetine is effective for
management of pain for some patients, as well as predictors of who is likely to benefit from
duloxetine. The original protocol was designed as a randomized, placebo-controlled cross-over
trial, with planned enrollment of a total of 84 women with early stage breast cancer who have
chronic pain following treatment, as well as 48 women who are pain free. However because of
challenges with logistics of the protocol and pain testing, the trial was redesigned after
only 7 patients with pain were enrolled. The new design was a single arm trial, and all
patients with pain were treated with duloxetine (no placebo); there was still a non-treatment
comparator arm of patients without pain. Patients were enrolled first at the University of
Michigan and then the University of Utah. A total of 39 patients with pain and 43 controls
without pain were enrolled before the trial closed to enrollment. All subjects underwent
assessment of pain sensitivity and completed questionnaires. Subjects with pain were treated
with duloxetine for a total of 7 weeks, with pain sensitivity assessments before treatment
and after 4 weeks of full-dose treatment. The data from the control patients (who did not
receive any study medication) are being compared to those from the patients with pain to
understand more about the differences between patients who do and do not experience
treatment-related pain, and to interpret the post-intervention patient-reported and pain
assessment results.
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