Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639417
• Other study ID #: UMCC 2011.115
• Secondary ID: HUM 55687
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: April 14, 2016
• Start date: May 2012
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to better understand why some women with breast cancer develop chronic pain.

Description:

Women with breast cancer who either have chronic pain or who do not have chronic pain will be asked to enroll. Those who participate will have pictures taken of their brain using MRI when they are lying still and also when pressure is being applied to their thumbnails. These pictures will be compared to patients without breast cancer who do not have pain and to those who have other types of pain, such as fibromyalgia. By taking and analyzing these pictures the investigators hope to understand more about why breast cancer survivors develop pain after their diagnosis and treatment. In the future the investigators hope to better treat the pain or possibly even prevent the pain from occurring in the first place.

Other known NCT identifiers

• NCT02180594

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast Cancer Survivor with and without chronic pain

• Able to undergo MRI

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain
• Mastodynia
• Pain

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Lynn Henry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of differences in pain sensitivity and functional MRI in different groups of patients.	The primary objective of this pilot trial is to determine if there may be differences in mechanical pain sensitivity and functional MRI brain activation patterns in breast cancer survivors with chronic pain as compared to breast cancer patients without chronic pain, to patients with fibromyalgia, or to healthy controls.	6 months	No