Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983982
• Other study ID #: HUM00077174
• Secondary ID: UMCC 2013.073
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: July 25, 2016
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Damon Runyon Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No