Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01028352
Status:
COMPLETED
Last Update Posted:
2013-08-08
First Post:
2009-12-08
Brief Title:
Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
UMCC 200862 Prospective Pilot Study Evaluating the Use of Duloxetine for Treatment of Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many women with breast cancer who are treated with aromatase inhibitor medications develop aches and pains during treatment and some develop numbness and tingling in their hands and feet Some examples of aromatase inhibitor medications include anastrozole Arimidex exemestane Aromasin and letrozole Femara Frequently pain medications do not work very well to relieve the pain Duloxetine Cymbalta is a medication that was originally developed to treat depression It has also been found to relieve pain that occurs in people with diabetes fibromyalgia arthritis and other painful conditions In this study we are testing to see if duloxetine will help treat the pain that can occur in women treated with aromatase inhibitors
Detailed Description:
Aromatase inhibitor AI therapy is commonly used for treatment of postmenopausal women with hormone receptor-positive breast cancer The most common toxicities are arthralgias and myalgias which can be difficult to manage and necessitate discontinuation of therapy in up to 10 of patients One potential interventional approach is with a pharmaceutical agent such as duloxetine which has been shown to be effective for treatment of other types of chronic pain including fibromyalgia and diabetic neuropathic pain
The primary objective of this pilot study is to determine the proportion of breast cancer patients with AI-associated musculoskeletal symptoms who experience a 30 reduction in average pain score from baseline to 8 weeks due to duloxetine treatment Participants will be treated with duloxetine for 8 weeks Questionnaires to evaluate pain functional status depression menopausal symptoms and sleep difficulties will be administered at baseline and after 2 4 6 and 8 weeks of therapy In addition 10 milliliters blood of will be drawn from the subjects at baseline for future pharmacogenetic evaluation If the results of this pilot study suggest that the efficacy of duloxetine therapy is greater than that expected from placebo based on historical controls then these data will be used to design future prospective placebo-controlled randomized trials of treatment with duloxetine in this patient population
The primary objective of this pilot study is to determine the proportion of breast cancer patients with AI-associated musculoskeletal symptoms who experience a 30 reduction in average pain score from baseline to 8 weeks due to duloxetine treatment Participants will be treated with duloxetine for 8 weeks Questionnaires to evaluate pain functional status depression menopausal symptoms and sleep difficulties will be administered at baseline and after 2 4 6 and 8 weeks of therapy In addition 10 milliliters blood of will be drawn from the subjects at baseline for future pharmacogenetic evaluation If the results of this pilot study suggest that the efficacy of duloxetine therapy is greater than that expected from placebo based on historical controls then these data will be used to design future prospective placebo-controlled randomized trials of treatment with duloxetine in this patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM00022455 | OTHER | University of Michigan Medical IRB | None |