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Arthralgia | Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

Arthralgia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arthralgia

Breast Cancer

Hot Flashes

Musculoskeletal Complications

Sexual Dysfunction

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:testosterone10.4 mg

Other:placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm IPatients receive testosterone (0.264mL) topical application daily for six months.

Arm IIPatients receive placebo (0.264mL) topical application daily for six months.

Study Status

Active, not recruiting

Start Date: August 2013

Completed Date:

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Intra-patient change in joint pain at 3 months from baseline as measured by item #3 (average) of the Brief Pain Inventory

Secondary Outcome: Incidence of toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Study sponsors, principal investigator, and references

Principal Investigator: Charles Loprinzi, MD

Lead Sponsor: Alliance for Clinical Trials in Oncology

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01573442

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