A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102

Cathcart-Rake, Elizabeth; Novotny, Paul J.; Leon‐Ferre, Roberto A.; Le‐Rademacher, Jennifer; Storrick, Elizabeth; Adjei, Araba A.; Terstriep, Shelby A.; Glaser, R. M.; Giuliano, Armando E.; Mitchell, W. R.; Page, Seth Joel; Austin, Colleen; Deming, Richard L.; Ferreira, Margaret A.; Lafky, Jacqueline M.; Birrell, Stephen N.; Loprinzi, Charles L.

doi:10.1007/s00520-020-05473-2

Cited by 10 publications

(7 citation statements)

References 49 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Both pharmacologic (duloxetine, 17 testosterone, 18 ω3 fatty acids, 19 and vitamin D 20 ) and nonpharmacologic interventions (exercise 21 ) have been studied to treat AI-associated arthralgias with mixed results. Most of these trials did not assess or did not find long-term benefits.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

et al. 2022

View full text Add to dashboard Cite

ImportanceAromatase inhibitors (AIs) have proven efficacy for the treatment of hormone-sensitive breast cancer; however, arthralgias (pain and stiffness) contribute to nonadherence with therapy for more than 50% of patients.ObjectiveTo examine the effect of acupuncture in reducing AI-related joint pain through 52 weeks.Design, Setting, and ParticipantsA randomized clinical trial was conducted at 11 sites in the US from May 1, 2012, to February 29, 2016, with a scheduled final date of follow-up of September 5, 2017, to compare true acupuncture (TA) with sham acupuncture (SA) or waiting list control (WC). Women with early-stage breast cancer were eligible if they were taking an AI and scored 3 or higher on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain). Analysis was conducted for data received through May 3, 2021.InterventionsParticipants were randomized 2:1:1 to the TA (n = 110), SA (n = 59), or WC (n = 57) group. The TA and SA protocols were composed of 6 weeks of intervention at 2 sessions per week (12 sessions overall), followed by 6 additional weeks of intervention with 1 session per week. Participants randomized to WC received no intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.Main Outcomes and MeasuresIn this long-term evaluation, the primary end point was the 52-week BPI-WP score, compared by study group using linear regression, adjusted for baseline pain and stratification factors.ResultsAmong 226 randomized women (mean [SD] age, 60.7 [8.6] years; 87.7% White; mean [SD] baseline BPI-WP score, 6.7 [1.5]), 191 (84.5%) completed the trial. In a linear regression, 52-week mean BPI-WP scores were 1.08 (95% CI, 0.24-1.91) points lower in the TA compared with the SA group (P = .01) and were 0.99 (95% CI, 0.12-1.86) points lower in the TA compared with the WC group (P = .03). In addition, 52-week BPI pain interference scores were statistically significantly lower in the TA compared with the SA group (difference, 0.58; 95% CI, 0.00-1.16; P = .05). Between 24 and 52 weeks, 12 (13.2%) of TA, 6 (11.3%) of SA, and 5 (10.6%) of WC patients reported receipt of acupuncture.Conclusions and RelevanceIn this randomized clinical trial, women with AI-related joint pain receiving 12 weeks of TA had reduced pain at 52 weeks compared with controls, suggesting long-term benefits of this therapy.Trial RegistrationClinicalTrials.gov Identifier: NCT01535066

show abstract

Section: Discussionmentioning

confidence: 99%

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

et al. 2022

View full text Add to dashboard Cite

show abstract

“…was a clinical consultant to the Mayo Clinic for the ''Alliance Trial A221102, a Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone (pellets) in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias.'' 71 Patients receiving subcutaneous T + A implants reported statistically significant improvements in hot flashes, fatigue, mood swings, urinary incontinence, and skin appearance, tone, and texture. 71 However, the 120-mg T implant dose (with 8 mg anastrozole) did not (significantly) relieve arthralgias in patients on oral AIs.…”

Section: Original Datamentioning

confidence: 98%

“…71 Patients receiving subcutaneous T + A implants reported statistically significant improvements in hot flashes, fatigue, mood swings, urinary incontinence, and skin appearance, tone, and texture. 71 However, the 120-mg T implant dose (with 8 mg anastrozole) did not (significantly) relieve arthralgias in patients on oral AIs. The investigators surmised that the dose of subcutaneous T was too low.…”

Section: Original Datamentioning

confidence: 98%

Testosterone Implant Therapy in Women With and Without Breast Cancer: Rationale, Experience, Evidence

Glaser

Dimitrakakis

2021

Androgens: Clinical Research and Therapeutics

Self Cite

View full text Add to dashboard Cite

Testosterone (T) is the most abundant biologically active hormone in women. It has a direct effect at the androgen receptor in every major organ system. Local aromatization of T is a major source of bioavailable estradiol. Adequate amounts of bioavailable T are essential for optimal health, immune function, and disease prevention. More than 80% of bioavailable T in women is from the local intracrine production of T from the adrenal precursor steroids androstenedione and dehydroepiandrosterone (sulfate). Serum T levels reflect <20% of the total androgen pool in women, which limits its usefulness in diagnosing or treating androgen deficiency. The gradual decline of androgens associated with aging is responsible for many of the adverse signs and symptoms of aging, including mental and physical deterioration. Decades of evidence support the safety and efficacy of T therapy in women. We have found that subcutaneous T implant therapy relieves symptoms of hormone deficiency in women with and without breast cancer, improves their quality of life, and maintains overall health and wellbeing. T does not increase and may lower the risk of breast cancer. The combination of T with an aromatase inhibitor prevents the conversion of androgens to estrogens, limiting their stimulatory effect in estrogensensitive diseases, including breast cancer. Adequate doses of T therapy should provide adequate levels of bioavailable T in the target organs-determined by clinical response (benefits) versus adverse side effects (risks). Pharmacological dosing of T implants in women is safe and necessary for physiological effect.

show abstract

“…As much of the pharmacological (e.g., duloxetine, Henry et al, 2018; testosterone, Cathcart-Rake et al, 2021; ω3 fatty acids, Shen et al, 2018; vitamin D, Niravath et al, 2019) and nonpharmacologic (e.g., exercise, Irwin et al, 2015) literature has been mixed in regard to efficacy, we view the present results as both clinically meaningful and helpful to patients with MSP. In the present study, the largest adjusted mean-between-group difference on BPI-SF severity between the hypnosis and AC groups—occurred at 6 months and was 1.14 points.…”

Section: Discussionmentioning

confidence: 79%

A randomized controlled trial of hypnosis to manage musculoskeletal pain in breast cancer survivors taking aromatase inhibitors.

Montgomery,

Schnur,

Tiersten

et al. 2024

Psychology of Consciousness: Theory, Research, and Practice

View full text Add to dashboard Cite

A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102

Cited by 10 publications

References 49 publications

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

Testosterone Implant Therapy in Women With and Without Breast Cancer: Rationale, Experience, Evidence

A randomized controlled trial of hypnosis to manage musculoskeletal pain in breast cancer survivors taking aromatase inhibitors.

Contact Info

Product

Resources

About