Abstract P3-12-02: Lifestyle interventions combined with acupuncture-like transcutaneous electrical nerve stimulation in managing vasomotor symptoms induced by breast cancer treatment: Results of a phase 2 randomized controlled trial
Authors: Forbes Margaret , Wong Raimond , Sagar Stephen M , Julian Jim A , Levine Mark N , Hayward Joseph 
Published: May 2015

Background: Women with breast cancer can experience significant treatment induced vasomotor symptoms (TIVS). Non-hormonal strategies for TIVS (e.g. acupuncture, Venlafaxine) provide some relief but may be intolerable because of the invasive nature of the treatment and possible side effects. As such, women often prefer lifestyle strategies (LS) that can be self-administered. Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) is a non-invasive needleless technique that uses specific electrical parameters to stimulate selected acupoints to achieve clinical response with minimal toxicity. ALTENS can be administered with minimal training. It is amenable to quality assurance and can allow for self treatment by women. This study aimed to evaluate the efficacy of ALTENS in addition to LS in relieving TIVS in women with breast cancer.

Methods: Eligible subjects were postmenopausal women with Stages 0-3 breast cancer who had completed cancer treatment and were experiencing hot flashes for ≥ one month with a Hot Flash Score (HFS) ≥15 in one week prior to consent. Anti-estrogen therapy was permitted. Non-hormonal drug therapies were prohibited. Subjects were randomized to either LS (control) or LS with concurrent ALTENS (combined). LS consisted of standardized lifestyle strategies (e.g. environmental control, managing hot flash triggers) counseling delivered by a specially trained nurse practitioner at week 0 with reinforcing counseling at weeks 12 and 24. ALTENS was given twice weekly for 12 treatments over an 8-week period. The HFS, Hot Flash Related Daily Interference Scale and the Short Form version 2 health survey were administered at weeks 0, 12 and 24. Heart rate variability was measured at weeks 0 and 12. The primary study endpoint was the number of responders, defined as women who had &gt; 50% reduction in their HFS between weeks 0 and 12.

Results: 71 eligible subjects with a median age of 52 (range: 40-87) were randomized to combined arm (n=36) and control (n=35). At 12 weeks there were 11 (30.6%) responders in the combined arm versus 2 (5.7%) in the control (p=0.012).The results at 24 weeks were 14 versus 4, respectively (p=0.013). Arms were balanced for anti-estrogen use. Two subjects chose to discontinue ALTENS after experiencing symptoms improvement. There were no serious adverse events.

Conclusion: ALTENS in combination with lifestyle strategies is a promising non-pharmacologic approach that showed improvement in managing treatment induced vasomotor symptoms in women with breast cancer. Our trial results support its evaluation in phase 3 studies.

Citation Format: Margaret Forbes, Raimond Wong, Stephen M Sagar, Jim A Julian, Mark N Levine, Joseph Hayward. Lifestyle interventions combined with acupuncture-like transcutaneous electrical nerve stimulation in managing vasomotor symptoms induced by breast cancer treatment: Results of a phase 2 randomized controlled trial [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-12-02.