Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms in Early Stage Breast Cancer

University of Michigan1 site in 1 country30 target enrollmentNovember 2013

ConditionsBreast Cancer Chronic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: University of Michigan
Enrollment: 30
Locations: 1
Primary Endpoint: Feasibility of recruiting patients at chemotherapy initiation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. We are also investigating whether a patient's sensitivity to pain is related to how many symptoms she experiences during treatment.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

January 2016

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

N. Lynn Henry

Assistant Professor of Internal Medicine, Medical School

University of Michigan

Eligibility Criteria

Inclusion Criteria

•Female gender
•Histologically proven stage I-III invasive carcinoma of the breast who is planning to receive a standard dose of adjuvant chemotherapy.
•Surgical resection should be complete at the time of study enrollment.
•Eastern Cooperative Oncology Group performance status 0-2.

Exclusion Criteria

•Average pain over the past 24 hours of 4 or greater on a 0-10 scale.
•Peripheral sensory neuropathy grade 2 or higher.
•Personal history of schizophrenia or major depressive disorder, or history of suicidal ideation or attempt within the past 2 years.
•Thumbnail abnormalities on either hand (such as artificial nails) that are likely to alter pain perception during testing.
•Pregnant or nursing.
•No prior chemotherapy for any reason

Outcomes

Primary Outcomes

Feasibility of recruiting patients at chemotherapy initiation

Time Frame: 15 weeks

Feasibility will be measured by the proportion of women who complete the post-chemotherapy assessment among those consenting to participate in the trial.

Secondary Outcomes

Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain(15 weeks)
Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy(15 weeks)