Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adjuvant chemotherapy

Subjects will undergo pain testing, then receive standard of care chemotherapy, and then undergo pain testing.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No