Trial Outcomes & Findings for Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients (NCT NCT01814397)

Last Updated: 2024-02-07

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Baseline, 3 months, 6 months

Results posted on

2024-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Women Starting AI 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 STARTED	50
Overall Study 3 Month Evaluation	43
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Women Starting AI 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 Adverse Event	7
Overall Study Withdrawal by Subject	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women Starting Aromatase Inhibitor (AI) Therapy n=50 Participants 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.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Weight, kg	80.7 kilograms STANDARD_DEVIATION 17.8 • n=5 Participants
Body mass index	30.0 kg/m^2 STANDARD_DEVIATION 6.5 • n=5 Participants
Aromatase inhibitor anastrozole 1 mg daily	40 participants n=5 Participants
Aromatase inhibitor exemestane 25 mg daily	1 participants n=5 Participants
Aromatase inhibitor letrozole 2.5 mg daily	9 participants n=5 Participants
Prior chemotherapy prior chemotherapy	23 participants n=5 Participants
Prior chemotherapy no prior chemotherapy	27 participants n=5 Participants
Prior tamoxifen prior tamoxifen	14 participants n=5 Participants
Prior tamoxifen no prior tamoxifen	36 participants n=5 Participants
Mean Pain50, kg/cm^2	4.3 kg/cm^2 STANDARD_DEVIATION 1.5 • n=5 Participants
Mean conditioned pain modulation (CPM)	7.9 units on a scale (0-100 pain scale) STANDARD_DEVIATION 14.7 • n=5 Participants
Mean serum estradiol, pg/ml	6.0 pg/ml STANDARD_DEVIATION 7.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months

Outcome measures

Outcome measures
Measure	Women Starting AI Therapy n=50 Participants 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.
Mean Pain50 Assessed at Baseline, 3 Months and 6 Months Baseline	4.3 kg/cm^2 Standard Deviation 1.5
Mean Pain50 Assessed at Baseline, 3 Months and 6 Months 3 month	4.2 kg/cm^2 Standard Deviation 1.8
Mean Pain50 Assessed at Baseline, 3 Months and 6 Months 6 month	4.2 kg/cm^2 Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months

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.

Outcome measures

Outcome measures
Measure	Women Starting AI Therapy n=50 Participants 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.
Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months 3 months	6.3 units on a scale (0-100 pain scale) Standard Deviation 18.4
Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months baseline	7.9 units on a scale (0-100 pain scale) Standard Deviation 14.7
Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months 6 months	10.4 units on a scale (0-100 pain scale) Standard Deviation 18.9

OTHER_PRE_SPECIFIED outcome

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

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.

Outcome measures

Outcome measures
Measure	Women Starting AI Therapy n=50 Participants 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.
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 pain, no discontinuation by 6 mo	1.6 units on a scale Standard Deviation 1.3
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 depression, discontinuation by 6 mo	14 units on a scale Standard Deviation 9.5
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 depression, no discontinuation by 6 mo	6.6 units on a scale Standard Deviation 5.9
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 sleep, discontinuation by 6 mo	47.1 units on a scale Standard Deviation 17.9
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 sleep, no discontinuation by 6 mo	28.6 units on a scale Standard Deviation 17.8
Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment BL general fatigue, discontinuation by 6 mo	16.9 units on a scale Standard Deviation 3.6
Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment BL general fatigue, no discontinuation by 6 mo	10.6 units on a scale Standard Deviation 4.1
Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment BL pain, discontinuation by 6 mo	1.9 units on a scale Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months

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.

Outcome measures

Outcome measures
Measure	Women Starting AI Therapy n=50 Participants 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.
Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy Baseline	6.0 pg/ml Standard Deviation 7.6
Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy 3 months	0.75 pg/ml Standard Deviation 0.45

Adverse Events

Women Starting AI Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Norah Lynn Henry

University of Michigan Comprehensive Cancer Center

Phone: 734-936-4991

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place