Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients

NCT01814397 | Completed Results DMC

• 2 other identifiers: UMCC 2008.101HUM00026034
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Postmenopausal women who have hormone receptor positive breast cancer are typically treated with aromatase inhibitor medications, which substantially decrease the amount of estrogen produced by their bodies. These medications are fairly well tolerated, but can cause aches and pains which can be quite severe in some cases. People experience pain differently. Estrogen appears to play a role in how we experience pain. Therefore, decreasing estrogen levels may lead to more pain in some women than others. The goal of this study is to evaluate perception of pain in women with breast cancer, and to determine if differences in pain perception lead to more aches and pains in some women treated with aromatase inhibitors. In this study, we plan to enroll 55 women with breast cancer who are starting treatment with an aromatase inhibitor. Participants will undergo testing to evaluate their perception of pain, and will also complete a set of questionnaires. Testing will be conducted before starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. We will investigate whether pre-existing differences in pain perception lead to different amounts of pain during aromatase inhibitor therapy.

Conditions

Breast Cancer; Pain; Arthralgia

Keywords

Aromatase inhibitor; Pain threshold

Outcome Measures

Primary Outcomes (1)

• Mean Pain50 Assessed at Baseline, 3 Months and 6 Months

  Patients rated the intensity of each pressure sensation using a 0 to 100 numerical rating scale (0 = no pain, 100 = worst pain imaginable). Pain50 was defined as the amount of applied pressure in kilograms per square centimeter that evoked a pain intensity rating of 50 out of 100. Pain50 was assessed at baseline, 3 months, and 6 months. Change in Pain50 with estrogen depletion was determined.

  Baseline, 3 months, 6 months

Secondary Outcomes (1)

• Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months

  Baseline, 3 months, 6 months

Other Outcomes (2)

• Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment

  Baseline patient-reported outcomes measures, 6 month persistence with therapy

• Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy

  Baseline, 3 months

Study Arms (1)

Women starting AI therapy

There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.

Drug: Anastrozole; Drug: exemestane; Drug: letrozole

Interventions

Anastrozole DRUG

1 mg orally daily

Also known as: Arimidex

Women starting AI therapy

exemestane DRUG

25 mg orally daily

Also known as: Aromasin

Women starting AI therapy

letrozole DRUG

2.5 mg orally daily

Also known as: Femara

Women starting AI therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women with ER positive early stage breast cancer who are starting AI therapy

You may qualify if:

• Female gender
• Postmenopausal, age 21 or greater
• Stage 0-III estrogen receptor and/or progesterone receptor positive breast cancer who will be receiving a standard dose of letrozole, anastrozole, or exemestane
• Performance status 0-2
• Willing to sign the consent form

You may not qualify if:

• Average pain \>=8/10 over the past 24 hours
• Peripheral sensory neuropathy grade 2 or higher
• Personal history of schizophrenia, or suicidal ideation or attempt within the past 2 years
• Thumbnail abnormalities on either hand that are likely to alter pain perception during testing

Sponsors & Collaborators

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

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Henry NL, Conlon A, Kidwell KM, Griffith K, Smerage JB, Schott AF, Hayes DF, Williams DA, Clauw DJ, Harte SE. Effect of estrogen depletion on pain sensitivity in aromatase inhibitor-treated women with early-stage breast cancer. J Pain. 2014 May;15(5):468-75. doi: 10.1016/j.jpain.2014.01.487. Epub 2014 Jan 22.

  PMID: 24462504 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Baseline: whole blood for DNA, serum, plasma 3 month: serum, plasma 6 month: serum

MeSH Terms

Conditions

Breast Neoplasms; Pain; Arthralgia

Interventions

Anastrozole; exemestane; Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Norah Lynn Henry
• Organization: University of Michigan Comprehensive Cancer Center

norahh@med.umich.edu

734-936-4991

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 7, 2024
• Results First Posted: August 4, 2014

Record last verified: 2024-01

Locations

US (1)