Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
- To determine whether testosterone will reduce aromatase inhibitor (AI)-induced
arthralgia and associated joint symptoms.
- To explore whether testosterone will have an acceptable safety and tolerability
profile, with particular reference to androgenic adverse events including acne,
hirsutism, and alopecia.
- To explore whether testosterone will reduce AI-induced arthralgias and associated joint
symptoms and their interference with activity. (Ancillary)
- To explore whether testosterone will reduce the incidence of hot flashes. (Ancillary)
- To explore whether testosterone will modify libido or change quality of life.
- To explore whether identified single nucleotide polymorphisms (SNPs), that were
associated with more AI-associated arthralgias in a previous prospective trial, are
more commonly seen in the patients entered into the present clinical trial, than are
observed in the normal population. (Ancillary)
OUTLINE: This is a multicenter study. Patients are stratified according to baseline pain
score (5-6 vs 7-10) and age in years (< 50 vs 50-60 vs > 60). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive testosterone transdermally on day 1 and then at 3 months.
- Arm II: Patients receive placebo transdermally on day 1 and then at 3 months. Blood
samples are collected at baseline and during treatment for correlative studies.
Patients complete the Hot Flash Diary daily for 2 months and the Profile of Mood States
(POMS), the Hot Flash Related Daily Interference Scale (HFRDIS), the Modified Brief Pain
Inventory, and the Menopause Specific Quality of Life Questionnaire (MENQOL) at baseline,
after completion of treatment, and at 6 months.
After completion of study treatment, patients are followed up for 6 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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)
Charles L. Loprinzi, MD
North Central Cancer Treatment Group