Abstract PD8-04: The role of Yoga as a complementary therapy in women undergoing treatment for breast cancer: A randomized controlled trial
Authors: Nair Nita S. , Goel Nishu S. , Parmar Vani , Dewade Ashwini , Siddique Shabina , Pandey Aarti , Hawaldar Rohini , Badwe Rajendra 
Published: March 2023

Background: Yoga has been tested in multiple small-randomized studies for its impact on quality of life (QOL) on breast cancer (BC). We conducted a randomized controlled trial, to study the effect of yoga on disease free survival as the primary endpoint in women with operable breast cancer. (NCT02161900). Methods: Women with non-metastatic BC during and after standard treatment, were randomized to yoga and conventional exercise(YCE) versus conventional exercise only(CE). The primary endpoint was disease free survival (DFS) with secondary endpoints of overall survival (OS) and QOL, which was assessed using the EORTC QLQC30, BR23, Brief fatigue inventory (BFI), Visual pain scores (VPS) and a spirituality questionnaire (SQ). EORTC QLQ was assessed at baseline (BL), 6-9 months (mo), 18-21 mo. BFI and VPS at BL, 6-8 mo and 12-15 mo and SQ at BL and 12-15 mo. We report the final analysis of DFS, OS and QOL in 850 women randomized to the study. The groups were balanced for clinic-pathologic factors in both arms. Results: Of the 850 women randomized on the study, 426 were on YCE arm and 424 on CE arm. The median age was 47 versus (vs) 48 years, median pT size was 3 vs 2.85cm, grade 3 tumors were 82.7 vs 82.1%, hormone receptor positive was in 69% vs 69.4% and HER2neu positive was in 14.4 vs13.7% in YCE and CE arms respectively. At a median follow-up of 80 months the disease fee survival was 80% vs 76.7% (HR= 0.85, 95% CI= 0.64 – 1.14, p=0.28), and overall survival was 85.4% vs 83.1% (HR= 0.86, 95%CI = 0.61 – 1.21, p=0.38) in YCE and CE respectively. Physical(p=0.043) and emotional function (0.017), fatigue (p=0.002), pain (p=0.031), appetite loss (&lt; 0.001) arm symptoms (0.035) and systemic therapy side effects (0.036) reduced at 6-9mo in YCE, with sustained improvements in physical (p=0.036) and emotional function (p=0.008) at 54mo. The median score of fatigue after adjuvant therapy measured by QLQ C30 was lower in YCE compared to CE (11.11vs 22.22, p = 0.002). Similarly, in BFI the baseline median scores of severity of fatigue were 5 in YCE and 6 in CE which reduced to 3 at one year in both groups. A further reduction to 0 was observed in the YCE arm at 2 years and then sustained till 4 years compared to the median score of fatigue in CE which stayed at 3. (p=0.04, 0.03 2 and 4 years respectively). In VPS the number of patients experiencing severe pain in YCE group were less than CE group with specific reduction noted in pain over the breast/chest wall (p=0.018 at 24mo). Lastly SQ assessed spirituality and showed no difference, but less deterioration compared to baseline scores were noted in YCE. Fifty-three percent women on YCE showed an improvement in QOL from baseline compared to 47% in CE, however the global score of QOL did not differ significantly between the two arms. This cohort had overall compliance of 61% to yoga and physiotherapy in YCE with 91.75% compliance among those who did yoga for 6-9mo and 85% to physiotherapy alone in CE. Conclusions: Yoga resulted in a 15% relative improvement in DFS and 14% in OS, that did not reach statistical significance in this trial. Yoga is a low-risk, low-cost therapy that improves day-to-day activity, including pain, fatigue and quality of life in women with breast cancer.This is the first study where the long term benefits in quality of life have been noted with the addition of yoga for women undergoing treatment for breast cancer.

Citation Format: Nita S. Nair, Nishu S. Goel, Vani Parmar, Ashwini Dewade, Shabina Siddique, Aarti Pandey, Rohini Hawaldar, Rajendra Badwe. The role of Yoga as a complementary therapy in women undergoing treatment for breast cancer: A randomized controlled trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD8-04.