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

April 6, 2012
August 29, 2013
August 2013
December 2013   (final data collection date for primary outcome measure)
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 ]
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) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01573442 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 [ 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 [ Designated as safety issue: No ]
  • The change of hot flashes during the first two months from baseline as measured by hot flash diary [ Designated as safety issue: No ]
  • The change of libido and menopause-specific quality of life from baseline as measured by MENQOL and POMS monthly [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Arthralgia
  • Breast Cancer
  • Hot Flashes
  • Musculoskeletal Complications
  • Sexual Dysfunction
  • Drug: therapeutic testosterone
    Given transdermally
  • Other: placebo
    Given transdermally
  • Experimental: Arm I
    Patients receive testosterone transdermally on day 1 and then at 3 months.
    Intervention: Drug: therapeutic testosterone
  • Placebo Comparator: Arm II
    Patients receive placebo transdermally on day 1 and then at 3 months.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
224
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States
 
NCT01573442
A221102, CDR0000730083, NCI-2012-00719, U10CA037447
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP