Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

Completed

• Conditions: Breast Cancer; Chronic Pain

• Registration Number: NCT01983982
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of recruiting patients at chemotherapy initiation	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 Outcome Measures

Name	Time	Method
Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain	15 weeks	Exploratory analyses will be conducted to examine associations between either baseline or change in quantitative sensory testing measures and change in patient-reported outcomes.
Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy	15 weeks	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.

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States