Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

Study Overview
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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.

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

Conditions
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Breast Cancer, Chronic Pain

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adjuvant chemotherapy<br>Subjects will undergo pain testing, then receive standard of care chemotherapy, and then undergo pain testing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Chemotherapy, Chronic Pain, Survivorship