Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms

University of Michigan

Status: Completed

Conditions: Breast Cancer; Chronic Pain

Study type: Observational

Funder types: Other

Identifiers

NCT01983982

HUM00077174

UMCC 2013.073 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

30 participants in 1 patient group

Adjuvant chemotherapy

Description:

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