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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 August 2017 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: August 15, 2017
Last verified: August 2017
April 6, 2012
August 15, 2017
August 2013
November 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 ]
  • 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 ]
    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 ]
  • The intra-patient changes in joint pain at each month from baseline as measured by the BPI-AIA. [ Time Frame: Up to 6 months ]
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)
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 ]
  • Alopecia as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  • Acne as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  • Hirsutism as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  • The change of hot flashes during the first two months from baseline as measured by hot flash diary [ Time Frame: Up to 2 months ]
  • The change of libido from baseline as measured by POMS monthly. [ Time Frame: Up to 6 months ]
  • The change of menopause specific quality of life from baseline as measured by MENQOL monthly. [ Time Frame: Up to 6 months ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
  • The intra-patient change in joint pain and its interference of activity for each month from baseline as measured by BPI-AIA
  • The change of hot flashes during the first two months from baseline as measured by hot flash diary
  • The change of libido and menopause-specific quality of life from baseline as measured by MENQOL and POMS monthly
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 (Participant, 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
November 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Charles Loprinzi, MD (507) 284-4565
Puerto Rico,   United States
 
 
NCT01573442
A221102
CDR0000730083 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-00719 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
U10CA037447 ( U.S. NIH Grant/Contract )
UG1CA189823 ( U.S. NIH Grant/Contract )
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
August 2017

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