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NCT Number: NCT01983982

Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Damon Runyon Cancer Research Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 14, 2013
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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