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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01573442
First received: April 6, 2012
Last updated: November 16, 2016
Last verified: November 2016

April 6, 2012
November 16, 2016
August 2013
March 2017   (final data collection date for primary outcome measure)
  • Intra-patient change in joint pain at 3 months from baseline as measured by item #3 (average) of the Brief Pain Inventory [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Proportion of women with changes in pain at least 10 points on a converted 0-100 scale at 3 months from baseline [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Proportion of women with an improvement (reduced pain) of at least 10 points (on a converted 0-100 scale)
  • The intra-patient change in joint pain at 6 months from baseline as measured by item #3 (average) of the Brief Pain Inventory for aromatase inhibitor arthralgias (BPI-AIA). [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • The intra-patient changes in joint pain at each month from baseline as measured by the BPI-AIA. [ Time Frame: Up to 6 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
  • Incidence of toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0. [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Alopecia as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Acne as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Hirsutism as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • 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 from baseline as measured by POMS monthly. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • The change of menopause specific quality of life from baseline as measured by MENQOL monthly. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#1 (worst) of the BPI-AIA. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#2 (least) of the BPI-AIA. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#4 (right now) of the BPI-AIA. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • The intrapatient change in joint pain for each month from baseline as measured by item#5 (stiffness) of the BPI-AIA. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. [ Time Frame: Up to 6 months ] [ 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 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.

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.

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: testosterone
    10.4 mg
  • Other: placebo
  • Experimental: Arm I
    Patients receive testosterone (0.264mL) topical application daily for six months.
    Intervention: Drug: testosterone
  • Placebo Comparator: Arm II
    Patients receive placebo (0.264mL) topical application daily for six 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
March 2017   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact: Charles Loprinzi, MD (507) 284-4565
United States,   Puerto Rico
 
NCT01573442
A221102, CDR0000730083, NCI-2012-00719, U10CA037447, UG1CA189823
Yes
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Charles Loprinzi, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
November 2016

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