Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

N/ACompletedNCT01983982

University of Michigan30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Chronic Pain

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan Health System

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Feasibility of recruiting patients at chemotherapy initiation

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

Time frame: 15 weeks

Secondary Outcomes

Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy

Patients will undergo quantitative sensory testing to identify change in pain threshold and in the magnitude of conditioned pain modulation before chemotherapy and shortly after the final dose of chemotherapy.

Time frame: 15 weeks

Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain

Exploratory analyses will be conducted to examine associations between either baseline or change in quantitative sensory testing measures and change in patient-reported outcomes.

Time frame: 15 weeks

Data from ClinicalTrials.gov

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