PainPhase 2NCT01912612
Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain
A Phase 2 study testing Duloxetine in people with Pain, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2013to 28 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients at least 25 years of age
- Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment. All indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment. Concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted.
- Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture
- Patient-reported worst pain score between 5 and 10 (inclusive) on a 0-10 scale (assessed verbally)
- Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception
- Willing to withdraw from selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressants (TCA) prior to treatment initiation
- Patients who are currently taking non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, meloxicam, gabapentin, pregabalin) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Prior use of duloxetine or milnacipran.
- Prior or current use of venlafaxine specifically for treatment of pain (prior or current use for treatment of other indications, such as hot flashes, is permitted, although cases currently taking venlafaxine must discontinue use prior to study treatment initiation)
- Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin, or direct oral anticoagulants); treatment with monoamine oxidase inhibitor within 14 days prior to registration.
- Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing
- Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living
- Significant risk of suicide based on the Investigator's judgment
Show all 16Show fewer
- History or behavior that would, in the Investigator's judgment, prohibit compliance for the duration of the study.
- History of alcohol or other substance abuse or dependence within the year prior to registration
- Known chronic liver disease, end stage renal disease, or creatinine clearance <30 mL/min as defined by Cockcroft-Gault equation
- Uncontrolled narrow-angle glaucoma.
- Clinically significant coagulation disorder
- History of seizure disorder
- Pregnant or breast-feeding. Urine pregnancy test will be assessed at the baseline visit in women of child-bearing potential with chronic pain.
- Unable to take oral medications or any medical condition that would interfere with the absorption of study medication capsules.
- Currently taking SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or TCA regimen (including Wellbutrin) for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient's treating psychiatrist to taper cases off these medications prior to study treatment).
- Controls are patients without chronic pain who otherwise meet the following eligibility criteria (inclusion #1, 2, 8, exclusion #1, 2, 4, 5, worst pain score 0-1, and not currently on medication for pain)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48103
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- Duloxetine
- Keywords
- Breast cancer, Pain sensitivity
- Medical subject headings
- Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Patients with pain, duloxetine) | Experimental | Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks. Receives: Drug: Duloxetine |
| Arm 2 (Patients without pain -- control) | No intervention | Patient reported pain and symptoms assessment for comparison at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
- Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)
- 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)
- Range of pain score 0-10 (0=no pain; 10=worst pain)
Measured: 5 weeks
Secondary outcomes (18)
Change in Patient-reported Average Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
- Baseline: Mean average pain for all individual patients in arm 1 (intervention) and arm 2 (control)
- 5 weeks: Mean average pain for all individual patients in arm 1 (intervention)
- Range of pain score 0-10 (0=no pain; 10=worst pain)
Measured: 5 weeks
Change in Pain Interference Between Baseline and 5 Weeks of Treatment With Duloxetine
Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
- Baseline: Mean pain interference for all individual patients in arm 1 (intervention)
- 5 weeks: Mean pain interference for all individual patients in arm 1 (intervention)
- Range of pain interference score 0-10 (0=no interference; 10=worst interference)
Measured: 5 weeks
Change in Number of Sites of Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map.
- Baseline: Mean number of sites of pain for all individual patients in arm 1 (intervention)
- 5 weeks: Mean number of sites of pain for all individual patients in arm 1 (intervention)
- Range of number of sites of pain 0-35 (0=no pain; 35=every pre-defined body site has pain)
Measured: 5 weeks
Change in Fibromyalgia Symptom Severity Score Between Baseline and 5 Weeks of Treatment With Duloxetine
Fibromyalgia Symptom Severity Score will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map and Symptom Severity Scale.
- Baseline: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)
- Range of Fibromyalgia Symptom Severity Score 0-12 (0=not consistent with fibromyalgia; 12=most consistent with fibromyalgia)
Measured: 5 weeks
Change in PainDETECT Score Between Baseline and 5 Weeks of Treatment With Duloxetine
PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire.
- Baseline: Mean PainDETECT score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean PainDETECT score for all individual patients in arm 1 (intervention)
- Range of PainDETECT score -1-38 (-1=no neuropathic pain; 38=most consistent with neuropathic pain)
Measured: 5 weeks
Change in Neuropathy Between Baseline and 5 Weeks of Treatment With Duloxetine
Neuropathy will be assessed at baseline and 5 weeks for each individual patient using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire.
- Baseline: Mean neuropathy score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean neuropathy score for all individual patients in arm 1 (intervention)
- Range of neuropathy score 0-44 (0=no neuropathy; 44=most consistent with neuropathy)
Measured: 5 weeks
Change in Fatigue Between Baseline and 5 Weeks of Treatment With Duloxetine
Fatigue will be assessed at baseline and 5 weeks for each individual patient using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
- Baseline: Mean fatigue T score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean fatigue T score for all individual patients in arm 1 (intervention)
- Average fatigue T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more fatigue)
Measured: 5 weeks
Change in Sleep Disturbance Between Baseline and 5 Weeks of Treatment With Duloxetine
Sleep Disturbance will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Sleep Disturbance Short Form 8b v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
- Baseline: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)
- Average sleep disturbance T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more sleep disturbance)
Measured: 5 weeks
Change in Physical Function Between Baseline and 5 Weeks of Treatment With Duloxetine
Physical Function will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Physical Function Short Form 10a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
- Baseline: Mean physical function T score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean physical function T score for all individual patients in arm 1 (intervention)
- Average physical function T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=better physical function)
Measured: 5 weeks
Change in Anxiety Between Baseline and 5 Weeks of Treatment With Duloxetine
Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
- Baseline: Mean anxiety score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean anxiety score for all individual patients in arm 1 (intervention)
- Range of anxiety score 0-21 (0=no anxiety, 21=maximum anxiety)
Measured: 5 weeks
Change in Depression Between Baseline and 5 Weeks of Treatment With Duloxetine
Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
- Baseline: Mean depression score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean depression score for all individual patients in arm 1 (intervention)
- Range of depression score 0-21 (0=no depression, 21=maximum depression)
Measured: 5 weeks
Change in Cognitive Difficulties - Language Between Baseline and 5 Weeks of Treatment With Duloxetine
Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
- Baseline: Mean language score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean language score for all individual patients in arm 1 (intervention)
- Range of language score 0-40 (0=no language difficulties, 40=maximum language difficulties)
Measured: 5 weeks
Change in Cognitive Difficulties - Visual-Perceptual Ability Between Baseline and 5 Weeks of Treatment With Duloxetine
Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
- Baseline: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)
- Range of visual-perceptual ability score 0-30 (0=no visual-perceptual difficulties, 30=maximum visual-perceptual difficulties)
Measured: 5 weeks
Change in Cognitive Difficulties - Verbal Memory Between Baseline and 5 Weeks of Treatment With Duloxetine
Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
- Baseline: Mean verbal memory score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean verbal memory score for all individual patients in arm 1 (intervention)
- Range of verbal memory score 0-40 (0=no verbal memory difficulties, 40=maximum verbal memory difficulties)
Measured: 5 weeks
Change in Cognitive Difficulties - Visual-Spatial Memory Between Baseline and 5 Weeks of Treatment With Duloxetine
Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
- Baseline: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)
- Range of visual-spatial memory score 0-40 (0=no visual-spatial memory difficulties, 40=maximum visual-spatial memory difficulties)
Measured: 5 weeks
Change in Cognitive Difficulties - Attention/Concentration Between Baseline and 5 Weeks of Treatment With Duloxetine
Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
- Baseline: Mean attention/concentration score for all individual patients in arm 1 (intervention)
- 5 weeks: Mean attention/concentration score for all individual patients in arm 1 (intervention)
- Range of attention/concentration score 0-40 (0=no attention/concentration difficulties, 40=maximum attention/concentration difficulties)
Measured: 5 weeks
Change in Objectively Assessed Pain Sensitivity Between Baseline and 5 Weeks of Treatment With Duloxetine
Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50).
- Baseline: Mean Pain50 for all individual patients in arm 1 (intervention) and arm 2 (control)
- 5 weeks: Mean Pain50 for all individual patients in arm 1 (intervention)
- Range of Pain50 score: 0-10 kg/cm2 (higher number reflects higher pain threshold or lower pain sensitivity)
Measured: 5 weeks
Change in Objectively Assessed Conditioned Pain Modulation Between Baseline and 5 Weeks of Treatment With Duloxetine
Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing
- Baseline: Mean CPM for all individual patients in arm 1 (intervention) and arm 2 (control)
- 5 weeks: Mean CPM for all individual patients in arm 1 (intervention)
- Range of CPM score: -60 to +60 (more positive values reflect more impaired CPM)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study start30 Oct 2013
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Trial was initially a randomized cross-over design. Soon after study initiation the trial design was amended because of poor accrual, and instead was a single arm open label trial in which all patients with pain were treated with study drug. Since so few patients had been enrolled at the time of study redesign, the only data analyzed were from the single treatment arm portion of the trial, and the non-intervention (baseline only) comparator.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Lynn Henry, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912612
- Sponsor's protocol ID
- UMCC 2013.044
- Other IDs
- HUM00075181, HCI94979
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2013
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT01912612
- Acronym / sponsor ID
- UMCC 2013.044
- Conditions
- Pain
- Keywords
- Breast cancer, Pain sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 30 Oct 2013 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trial was initially a randomized cross-over design. Soon after study initiation the trial design was amended because of poor accrual, and instead was a single arm open label trial in which all patients with pain were treated with study drug. Since so few patients had been enrolled at the time of study redesign, the only data analyzed were from the single treatment arm portion of the trial, and the non-intervention (baseline only) comparator.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Patients with pain, duloxetine) | Experimental | Drug: DuloxetineDuloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks. |
| Arm 2 (Patients without pain -- control) | No intervention | –Patient reported pain and symptoms assessment for comparison at baseline. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients at least 25 years of age
- Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment. All indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment. Concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted.
- Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture
- Patient-reported worst pain score between 5 and 10 (inclusive) on a 0-10 scale (assessed verbally)
- Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception
Key exclusion criteria (16 listed)
- Prior use of duloxetine or milnacipran.
- Prior or current use of venlafaxine specifically for treatment of pain (prior or current use for treatment of other indications, such as hot flashes, is permitted, although cases currently taking venlafaxine must discontinue use prior to study treatment initiation)
- Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin, or direct oral anticoagulants); treatment with monoamine oxidase inhibitor within 14 days prior to registration.
- Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing
- Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaSubjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days. | Drug | Arm 1 (Patients with pain, duloxetine) |
Primary outcome
Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. * Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control) * 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention) * Range of pain score 0-10 (0=no pain; 10=worst pain)
18 secondary outcomes
Change in Patient-reported Average Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Pain Interference Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Number of Sites of Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Fibromyalgia Symptom Severity Score Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in PainDETECT Score Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Neuropathy Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Fatigue Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Sleep Disturbance Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Physical Function Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Anxiety Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Depression Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Cognitive Difficulties - Language Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Cognitive Difficulties - Visual-Perceptual Ability Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Cognitive Difficulties - Verbal Memory Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Cognitive Difficulties - Visual-Spatial Memory Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Cognitive Difficulties - Attention/Concentration Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Objectively Assessed Pain Sensitivity Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Change in Objectively Assessed Conditioned Pain Modulation Between Baseline and 5 Weeks of Treatment With Duloxetine
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lynn Henry, MD, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine in people with Pain, run by University of Michigan Rogel Cancer Center at 2 sites 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 8 inclusion and 16 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine (time frame: 5 weeks). 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 6 Aug 2020.