Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer, Hot Flash, Orthopedic, Psychiatric |
Therapuetic Areas: | Oncology, Psychiatry / Psychology, Orthopedics / Podiatry, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | August 2013 |
Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
This randomized phase III trial studies testosterone to see how well it works compared to
placebo in treating postmenopausal patients with arthralgia (joint pain) caused by
anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia
associated with the use of aromatase inhibitors, such as anastrozole or letrozole.
placebo in treating postmenopausal patients with arthralgia (joint pain) caused by
anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia
associated with the use of aromatase inhibitors, such as anastrozole or letrozole.
This is a randomized, placebo-controlled, phase III trial evaluating subcutaneous
testosterone for the alleviation of aromatase inhibitor induced arthralgia. A parallel group
design will be utilized for this two-arm study: subcutaneous testosterone vs. placebo.
Patients are stratified according to baseline pain score (5-6 vs. 7-10) and age (< 50 vs.
50-60 vs. > 60). The primary objective is to determine whether testosterone will reduce
AI-induced arthralgia and associated joint symptoms. The secondary objective is to explore
whether testosterone will have an acceptable safety and tolerability profile, with particular
reference to androgenic adverse events including acne, hirsutism, and alopecia.
Patients are followed up to six months as defined in the protocol.
testosterone for the alleviation of aromatase inhibitor induced arthralgia. A parallel group
design will be utilized for this two-arm study: subcutaneous testosterone vs. placebo.
Patients are stratified according to baseline pain score (5-6 vs. 7-10) and age (< 50 vs.
50-60 vs. > 60). The primary objective is to determine whether testosterone will reduce
AI-induced arthralgia and associated joint symptoms. The secondary objective is to explore
whether testosterone will have an acceptable safety and tolerability profile, with particular
reference to androgenic adverse events including acne, hirsutism, and alopecia.
Patients are followed up to six months as defined in the protocol.
Inclusion Criteria:
1. Age ≥ 18 years
2. Receiving anastrozole (1mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days
prior to registration and plan to continue it throughout the duration of study
3. Body Mass Index (BMI) between 18 and 35 kg/m^2
4. Women who have undergone a total mastectomy or breast conserving surgery for primary
breast cancer +/-chemo, +/-radiotherapy.
5. Must have BOTH ER and PR receptor-positive tumors and BOTH must be ≥26% positive.
Alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or
higher
6. Women who are postmenopausal by surgery, radiotherapy or presence of natural
amenorrhea ≥ 12 months
7. ≥ 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with
anastrozole or letrozole which is felt by the patient to be caused by their aromatase
inhibitor as defined in the protocol. Note: Patients may, or may not, be taking
non-opioid analgesics
8. Ability to complete questionnaire(s) by themselves or with assistance
9. ECOG Performance Status (PS) 0, 1 or 2
10. Willing to provide informed written consent
11. Willing to return to an Alliance enrolling institution for follow-up
12. Willing to provide blood samples for correlative research purposes
13. Laboratory values prior to registration as defined in the protocol:
1. Creatinine ≤1.5 x ULN
2. Hemoglobin > 11 g/dL
3. WBC > 3.0
4. Platelet Count > 100,000
5. SGOT (AST) ≤ 1.5 x ULN
Exclusion Criteria:
1. Presence of residual or recurrent cancer (locally or metastatic)
2. Diabetes mellitus or glucose intolerance, defined as a fasting glucose >125 mg/dL
3. History of coronary artery disease (angina or myocardial infarction)
4. Patients on hormone replacement therapy (HRT) ≤ 4 weeks prior to registration. This
includes the use of vaginal estrogen therapy.
5. Known hypersensitivity to any component of testosterone.
6. Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for
rash), inhaled sprays (e.g. for obstructive airway diseases), eye drops or local
insertion (e.g. intra-articular). Note: Short duration (< 2 weeks) of systemic
corticosteroids is allowed (e.g. for chronic obstructive pulmonary disease) but not
within 30 days prior to registration.
7. Receiving any other investigational agent
8. History of a deep venous thrombosis or a thromboembolism
9. Concurrent use of the aromatase inhibitor exemestane, as it is structurally similar to
an androgen
10. Concurrent radiation therapy or chemotherapy
11. Current or planned use of cyclosporine, anticoagulants, oxphenbutazone, insulin, oral
or injectable vitamin D doses over 4,000IU/day, or tamoxifen
We found this trial at
529
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Pekin, Illinois 61554
Principal Investigator: James L. Wade
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Bremerton, Washington 98310
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701 Doctors Dr
Kinston, North Carolina 28504
Kinston, North Carolina 28504
(252) 559-2200
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Phone: 252-559-2200
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
Principal Investigator: John A. Ellerton
Phone: 805-474-9143
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Armando E. Giuliano
Phone: 310-423-8965
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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777 Hemlock Street
Macon, Georgia 31201
Macon, Georgia 31201
(478) 633-1000
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Phone: 478-633-1226
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
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Phone: 907-212-6871
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Seattle, Washington 98104
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Phone: 907-212-6871
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Aberdeen, Washington 98520
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Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
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1 Akron General Ave
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Akron, Ohio 44307
(330) 344-6000
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1111 Duff Ave
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Anacortes, Washington 98221
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99504
Principal Investigator: Keith S. Lanier
Phone: 503-215-2614
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Anchorage, Alaska 98508
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Appleton, Wisconsin 54911
Principal Investigator: Matthias Weiss
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Principal Investigator: Sharad A. Ghamande
Phone: 706-721-1663
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
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(404) 851-8000
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Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
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Auburn, California 95603
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2000 Ogden Ave
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(630) 978-6200
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4305 New Shepherdsville Road
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1300 Anne Street NW
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Billings, Montana 59101
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406-237-7000
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300 N. Seventh St.
Bismarck, North Dakota 58501
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915 Highland Blvd
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Burlingame, California 94010
Burlingame, California 94010
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Butte, Montana 59701
Butte, Montana 59701
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210 W Walnut St
Canton, Illinois 61520
Canton, Illinois 61520
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
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789 Mt Auburn Rd
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Cape Girardeau, Missouri 63703
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Phone: 309-243-3605
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160 S Adams St
Carthage, Illinois 62321
Carthage, Illinois 62321
(217) 357-6877
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Castro Valley, California 94546
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Cedar Rapids, Iowa 52403
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
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Centerville, Ohio 45459
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Centralia, Illinois 62801
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505 S Plummer Ave
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Charleston, South Carolina 29414
Principal Investigator: Steven A. Akman
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Principal Investigator: Steven A. Akman
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Phone: 704-384-5369
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