Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

NCT01983982 | Completed

• 2 other identifiers: HUM00077174UMCC 2013.073
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chronic Pain

Keywords

Breast Cancer; Chemotherapy; Chronic Pain; Survivorship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy

  15 weeks

• Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain

  15 weeks

Study Arms (1)

Adjuvant chemotherapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Damon Runyon Cancer Research Foundation: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine, Medical School

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

US (1)