Neoplasms

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All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Quantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer

Testing with thermal sensor testing device, von Frey filaments, cotton wisp, turning fork, pressure gauge device

Niels Kroman, MD, DMSc

Henrik Kehlet, MD Ph.D DMSc

The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting, psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and psychosocial factors remain to be determined in large, detailed, well-described studies, including stratification to modern breast cancer treatment (sentinel node strategy/ radiotherapy/ chemotherapy). The present study will describe in detail preoperative psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and opioid-reduced analgesia with a detailed, early and late postoperative follow-up with neurophysiological assessment in the surgical area and randomised studies on preventive therapy.

Chronic Pain After Operation for Breast Cancer

Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer

Danish Breast Cancer Cooperative Group

Danish Cancer Society

Rigshospitalet, Denmark

Rune Gärtner MD

Musculoskeletal Diseases

Arthralgia

Breast Diseases

Skin Diseases

Joint Diseases

Antineoplastic Agents

All Drugs and Chemicals

Exemestane

Letrozole

Estrogens

Anastrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

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.

exemestane

letrozole

Norah L Henry, MD, PhD

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.

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

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

Prospective Pilot Study to Determine the Effect of Aromatase Inhibitor-induced Estrogen Depletion on Evoked Pain Threshold and Psychosocial Factors in Breast Cancer Patients

Patients completed 4 measures at baseline, before aromatase inhibitor therapy initiation. (1) Depression: Center for Epidemiologic Studies-Depression, scores 0-60, higher scores reflect more depression. (2) Pain: 7 day Pain Diary, scores 0-10, higher scores reflect more pain. (3) Fatigue: Multidimensional Fatigue Inventory, scores 4-20, higher scores reflect more fatigue. (4) Sleep: Medical Outcomes Study-Sleep, scores 0-100, higher scores reflect worse sleep. Persistence with aromatase inhibitor therapy was assessed at the 6 month timepoint. Mean baseline values for each measure were calculated for the cohort that persisted with aromatase inhibitor therapy and the cohort that was non-persistent.

Estradiol is being assessed using an ultrasensitive gas chromatography tandem mass spectroscopy-based assay. The lower limit of detection of the assay is 0.625 pg/ml. For patients whose serum estradiol concentrations were below the lower limit of detection, the value of 0.625 pg/ml was used to calculate the mean estradiol concentration and standard deviation at both baseline and 3 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.

To assess conditioned pain modulation, pressure equivalent to the patient's Pain50 was applied to the non-dominant thumbnail for 30 seconds (test stimulus), and the patient rated the intensity of the pressure on a 0-100 pain scale at 10 second intervals. Ten minutes later pressure (conditioning stimulus) was continuously applied to the dominant thumbnail for 60 seconds at the same Pain50 intensity. After 30 seconds, the test stimulus was again applied to the non-dominant thumbnail for 30 seconds and the patient rated the intensity every 10 seconds. Conditioned pain modulation magnitude was calculated as the difference (second minus first) in the mean of the 3 pain ratings to the test stimulus applied prior to and during the conditioning stimulus. Conditioned pain modulation was assessed at baseline, 3 months, and 6 months. Change over that time period was assessed. Higher conditioned pain modulation values indicate less efficient conditioned pain modulation.

Damon Runyon Cancer Research Foundation

University of Michigan Rogel Cancer Center

We only collected data related to the study specific procedures, not the standard of care aromatase inhibitor medication.

Women Starting AI Therapy

There is only a single cohort. Postmenopausal women with estrogen receptor 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.

Women Starting Aromatase Inhibitor (AI) Therapy

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Weight, kg

Body mass index

anastrozole 1 mg daily

exemestane 25 mg daily

letrozole 2.5 mg daily

Aromatase inhibitor

prior chemotherapy

no prior chemotherapy

Prior chemotherapy

prior tamoxifen

no prior tamoxifen

Prior tamoxifen

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.

Mean Pain50, kg/cm^2

Pressure equivalent to the patient's Pain50 was applied to the non-dominant thumbnail for 30 seconds (test stimulus), and the patient rated the intensity of the pressure on a 0-100 pain scale at 10 second intervals. Ten minutes later pressure (conditioning stimulus) was continuously applied to the dominant thumbnail for 60 seconds at the same Pain50 intensity. After 30 seconds, the test stimulus was again applied to the non-dominant thumbnail for 30 seconds and the patient rated the intensity every 10 seconds. CPM magnitude was calculated as the difference of the means of the 3 pain ratings.

Mean conditioned pain modulation (CPM)

Mean serum estradiol, pg/ml

Dr. Norah Lynn Henry

Baseline

3 month

6 month

Mean Pain50 Assessed at Baseline, 3 Months and 6 Months

baseline

3 months

6 months

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

Baseline depression, discontinuation by 6 mo

Baseline depression, no discontinuation by 6 mo

Baseline sleep, discontinuation by 6 mo

Baseline sleep, no discontinuation by 6 mo

BL general fatigue, discontinuation by 6 mo

BL general fatigue, no discontinuation by 6 mo

BL pain, discontinuation by 6 mo

Baseline pain, no discontinuation by 6 mo

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

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

There is only a single cohort. Postmenopausal women with hormone receptor 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.

Overall Study

Patients with advanced cancer entering chemotherapy or have reported pain as a result of cancer treatment.

Tests to find the threshold at which perceive stimuli.

Sensory Tests

Patrick M. Dougherty, PhD

The Aim of this Study is to examine the feasibility of using quantitative sensory testing procedures, widely applied to the experimental study of sensory processing in humans both with and without various pain syndromes, to now characterize the psychophysical properties of neuropathic pain that has developed as a consequence of cancer therapy. Skin punch biopsies will be performed in patients with chemotherapy-induced pain to determine whether the impairment of nerve function is due to actual retraction or loss of innervation to the skin in areas affected by sensory disturbance.

Study Participation:

Participants will be contacted either before their initiation of chemotherapy or following their referral to pain management service for neuropathic cancer treatment-related pain.

The sensory tests will take about 1 hour to complete. These tests will seek to find the threshold (a measure of sensitivity) at which you perceive stimuli, such as touch, coolness, warmth, hot/cold feeling and pinprick. You will be asked to rate the intensity of each of these stimuli that you perceive to be painful. You will also be asked to rate the intensity of stimuli that are at a fixed intensity above the pain threshold for most people. Your skin temperature using a radiometer, a scan of your fingers and/or toes, grooved peg board, a timed task to place pegs in slots, and pain scale rating will be collected. Each part of the sensory test are optional and will be collected when possible.

You may either be tested at repeated intervals throughout your chemotherapy or at later follow-up dates to check the length of symptoms.

Length of Study:

Your participation will be complete once you have completed all the sensory testing.

Healthy Controls:

Study Participation:

If you agree to take part in this study, you will take part in sensory tests. The sensory tests will take about 1 hour to complete. These tests will seek to find the threshold (a measure of sensitivity) at which you perceive stimuli, such as touch, coolness, warmth, hot/cold feeling and pinprick. You will be asked to rate the intensity of each of these stimuli that you perceive to be painful. You will also be asked to rate how severe the stimuli that are above the level considered painful by most people. Your skin temperature using a radiometer, a scan of your fingers and/or toes, grooved peg board, a timed task to place pegs in slots, and pain scale rating will be collected. Each part of the sensory test are optional and will be collected when possible.

A skin biopsy will also be performed. If you are taking anticoagulants (blood thinners), you may be asked to stop taking them for several days, before the procedure, due to the risk of bleeding. For the skin punch biopsy, the skin is numbed with lidocaine and cleaned with betadine and an alcohol swab. Once the skin is anesthetized (numb), a small amount of skin will be collected using a sterile 3 mm punch tool (knife). After removal of the skin, the area where you were tested will be wiped with a sterile gauze, and antibiotic ointment will be applied. Then, it will be covered with a band aid. You will be given a small supply of antibiotic ointment and band aids. You will be asked to clean the skin with soap and water twice each day and to apply the ointment and band aid.

Researchers will study the skin sample and compare it to skin samples from cancer patients, so that they can try to better understand the cause of pain that occurs because of cancer therapy.

Length of Study:

Your participation will be complete once you have completed the sensory testing and skin biopsy.

Psychophysical Studies of Cancer Therapy Pain

Psychophysical Studies of Cancer Therapy-Induced Pain: A Feasibility Study

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chronic Pain After Operation for Breast Cancer	NCT00739544	Pain Threshold	1	18 Years - 70 Years	Rigshospitalet, Denmark
Chronic Pain After Operation for Breast Cancer	NCT00739544	Pain Threshold	1	18 Years - 70 Years	Rigshospitalet, Denmark
Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients	NCT01814397	Breast Cancer Pain Arthralgia	Anastrozole exemestane letrozole	21 Years -	University of Michigan Rogel Cancer Center
Psychophysical Studies of Cancer Therapy Pain	NCT00515060	Advanced Cancer Pain	Sensory Tests	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pain threshold