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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01573442
First received: April 6, 2012
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

RATIONALE: Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

PURPOSE: This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia caused by anastrozole or letrozole.


Condition Intervention Phase
Arthralgia
Breast Cancer
Hot Flashes
Musculoskeletal Complications
Sexual Dysfunction
Drug: therapeutic testosterone
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • The intra-patient change in joint pain at 3 months from baseline as measured by the Brief Pain Inventory for aromatase-inhibitor arthralgias (BPI-AIA) [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of transdermal testosterone assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 and additional questionnaires, including alopecia, acne, and hirsutism as reported by the patient [ Time Frame: Up to 6 months post treatment ] [ Designated as safety issue: Yes ]
  • The intra-patient change in joint pain and its interference of activity for each month from baseline as measured by BPI-AIA [ Time Frame: Up to 6 months post treatment ] [ Designated as safety issue: No ]
  • The change of hot flashes during the first two months from baseline as measured by hot flash diary [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
  • The change of libido and menopause-specific quality of life from baseline as measured by MENQOL and POMS monthly [ Time Frame: Up to 6 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: August 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive testosterone transdermally on day 1 and then at 3 months.
Drug: therapeutic testosterone
Given transdermally
Placebo Comparator: Arm II
Patients receive placebo transdermally on day 1 and then at 3 months.
Other: placebo
Given transdermally

Detailed Description:

OUTLINE:

This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Patients receive testosterone transdermally on day 1 and then at 3 months on Arm I. Patients receive placebo transdermally on day 1 and then at 3 months on Arm II. The primary objective of the study is to determine whether testosterone will reduce aromatase inhibitor (AI)-induced arthralgia and associated joint symptoms. The secondary objective of the study 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. After completion of study treatment, patients are followed up for 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/-chemotherapy and +/-radiotherapy
  • Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration
  • Must have BOTH estrogen receptor-positive (ER+) and progesterone receptor-positive (PR+) tumors and BOTH must be ≥ 30% positive
  • ≥ 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 measured by verbally addressing the following question: "Please rate your pain by picking a number, from 0 to 10 (0 being none and 10 being as bad as you can imagine) that best describes your pain from your aromatase inhibitor breast cancer medication on AVERAGE, over the past week."
  • No presence of residual or recurrent cancer (locally or metastatic)

PATIENT CHARACTERISTICS:

  • Body Mass Index (BMI) between 18 and 32 kg/m²
  • Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea ≥ 12 months
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 1.5 times upper limit of normal (ULN)
  • ECOG Performance Status (PS) 0, 1, or 2
  • Serum creatinine ≤1.5 times ULN
  • Hemoglobin > 11 g/dL
  • White blood cell (WBC) > 3,000/mm³
  • Platelets > 100,000/mm³
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Willing to provide informed written consent
  • Willing to return to an Alliance enrolling institution for follow-up
  • Willing to provide blood samples for correlative research purposes
  • No diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL
  • No history of coronary artery disease (angina or myocardial infarction)
  • No known hypersensitivity to any component of testosterone
  • No history of a deep venous thrombosis or a thromboembolism

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No patients on hormone-replacement therapy (HRT) ≤ 4 weeks before prior to registration
  • No prolonged systemic corticosteroid treatment, except for topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops, or local injections (e.g., intra-articular)

    • Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g., for chronic obstructive pulmonary disease), but not within 30 days prior to registration
  • Not receiving any other investigational agent
  • No concurrent use of the aromatase inhibitor exemestane
  • No concurrent radiation therapy or chemotherapy
  • No current or planned use of cyclosporine, anticoagulants, oxyphenbutazone, insulin, oral or injectable vitamin D doses over 4,000 IU/day or tamoxifen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573442

  Show 151 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01573442     History of Changes
Other Study ID Numbers: A221102, CDR0000730083, NCI-2012-00719, U10CA037447
Study First Received: April 6, 2012
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
hot flashes
musculoskeletal complications
sexual dysfunction
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
arthralgia
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Hot Flashes
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Aromatase Inhibitors
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014