Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01983982

Enrollment

Registered

2013-11-14

Start date

2013-11-30

Completion date

2016-01-31

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Chronic Pain

Keywords

Breast Cancer, Chemotherapy, Chronic Pain, Survivorship

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of recruiting patients at chemotherapy initiation	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

Measure	Time frame	Description
Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy	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.
Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain	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.

Countries

United States

Outcome results