Abstract PS9-51: Secondary outcomes in a randomized controlled trial of acupuncture versus sham acupuncture and usual care in solid tumor survivors with chemotherapy-induced peripheral neuropathy

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is the most common and debilitating long-term adverse effect of neurotoxic chemotherapy and it significantly worsens cancer survivors’ quality of life. In a previously reported randomized controlled trial, we showed that real acupuncture is more effective in reducing persistent CIPN symptoms compared to usual care, with a trend of greater CIPN pain reduction compared to sham acupuncture (Bao et al, JAMA Netw Open, 2020). Here, we report secondary outcomes in this trial. Patients and Methods: Solid tumor survivors with persistent moderate to severe CIPN (symptoms of numbness, tingling, or pain rated ≥4 on a numeric rating scale [NRS]) were randomized to three arms: 1) Eight weeks of real acupuncture (RA); 2) eight weeks of sham acupuncture (SA); and 3) usual care (UC). The secondary endpoints were Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), Hospital Anxiety and Depression Score (HADS), and Insomnia Severity Index (ISI). For each endpoint, the mean changes from baseline and 95% confidence intervals (CI) were estimated within each arm and compared between arms using linear mixed models.Results: We enrolled and randomized 75 solid tumor survivors (53% breast cancer) with moderate to severe CIPN to the study. Compared to baseline, at week 8, FACT/GOG-Ntx, HADS anxiety, and ISI scores significantly improved in both RA and SA arms, but not in the UC arm (Table 1). At week 8, FACT/GOG-Ntx scores significantly increased in both RA and SA arms when compared with UC (p=0.001 and 0.007), indicating improved CIPN related symptoms and quality of life. There was no statistically significant difference between RA and SA arms, p=0.498. When comparing RA and SA with UC, we found no statistically significant difference in changes from baseline in HADS anxiety and ISI. Conclusions: Our study showed acupuncture may be effective in improving CIPN symptoms and reducing anxiety and insomnia in cancer survivors with persistent CIPN. Further large sample size studies are needed to delineate possible placebo effects from SA. Table 1. Secondary Outcomes in RA, SA, and UC Arms and Changes From BaselineReal Acupuncture(n=27)Sham Acupuncture (n=24)Usual Care (n=24)OutcomeWeekMean (95% CI)Change from Baseline,Mean (95% CI)Mean (95% CI)Change from Baseline,Mean (95% CI)Mean (95% CI)Change from Baseline,Mean (95% CI)FACT/GOG-Ntx024.41 (21.38, 27.44)NA25.13 (21.91, 28.34)NA27.01 (23.80, 30.22)NA828.60 (25.52, 31.67)4.19 (2.39, 5.99)***28.42 (25.19, 31.66)3.30 (1.45, 5.15)***26.61 (23.32, 29.89)-0.40 (-2.35, 1.54)HADS Anxiety06.61 (4.98, 8.25)NA7.66 (5.93, 9.39)NA6.52 (4.79, 8.25)NA85.61 (3.95, 7.27)-1.00 (-1.99, -0.01)*6.64 (4.89, 8.38)-1.02 (-2.03, -0.01)*6.76 (4.99, 8.53)0.24 (-0.81, 1.29)ISI012.93 (10.24, 15.61)NA12.46 (9.61, 15.31)NA10.17 (7.32, 13.02)NA810.63 (7.88, 13.37)-2.30 (-3.99, -0.61)**10.20 (7.33, 13.07)-2.26 (-3.99, -0.53)*8.96 (6.05, 11.87)-1.21 (-3.01, 0.60)Table Symbols: *, p < 0.05; **, p < 0.01; ***, p < 0.001 Citation Format: Ting Bao, Ray Baser, Crystal Lin, Qing Li, Lauren Piulson, Iris Zhi. Secondary outcomes in a randomized controlled trial of acupuncture versus sham acupuncture and usual care in solid tumor survivors with chemotherapy-induced peripheral neuropathy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-51.