Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

July 25, 2016 updated by: N. Lynn Henry, University of Michigan

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women initiating adjuvant chemotherapy to treat stage I-III breast cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Adjuvant chemotherapy
Subjects will undergo pain testing, then receive standard of care chemotherapy, and then undergo pain testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy
Time Frame: 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.
15 weeks
Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain
Time Frame: 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.
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Damon Runyon Cancer Research Foundation

Investigators

  • Principal Investigator: Norah L Henry, MD, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00077174
  • UMCC 2013.073 (Other Identifier: University of Michigan Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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