A single-arm pilot clinical trial of a 4-month whole systems ayurvedic nutrition and lifestyle intervention for breast cancer survivors

Purpose: Improving patient reported outcomes, including quality of life (QOL), for the estimated 16.9 million US breast cancer (BC) survivors is an important goal. We tested the feasibility and acceptability of a manualized intervention based on Ayurvedic medicine for BC survivors. Methods: Eligible participants with Stage I‐III BC, treated within the past year, received chemotherapy as part of their treatment, and were in remission when enrolled. The 4‐ month individualized Ayurvedic intervention included counseling on nutrition, lifestyle, yoga, and marma (acupressure) during 8 one‐on‐one visits with a practitioner. Feasibility and acceptability were the primary outcomes. Quality of life (QOL) (EORTC QLQ C30 BR23), sleep disturbance (GSDS), fatigue (LFS), depressive symptoms (CESD), anxiety (STAI), stress (PSS), and spiritual well‐being (FACIT) were measured prior to the intervention and at the end of month 4 as part of acceptability. Effect sizes (ES) were calculated along with paired t tests comparing baseline to end of month 4 timepoints. Results: Participants (n=32) had a mean age of 48 (SD=10), and 66% had stage II BC. Retention at 4months was 84%. Among those who completed the intervention (n=27), adherence was high (99.5% visits attended). Large improvements were seen in QOL emotional functioning (ES: 0.84, P=.0002); QOL cognitive functioning (ES:0.86, P= .0002); CES‐D depressive symptoms (ES:‐1.21, P=.00001); FACIT spiritual well‐being/peace (ES:0.86, P=.0007); and GSDS sleep disturbance (ES:‐1.23, P=.00001). Moderate improvements were seen in QOL Global Health (ES:0.65, P=.0027); QOL social functioning (ES:0.47 P=.025), LFS energy (ES:0.54, P=.011), LFS fatigue (ES:‐0.68, P=.0019); STAI state anxiety (ES:‐0.75, P=.0007); PSS stress (ES:‐ 0.75, P=.0002); and FACIT spiritual well‐being‐meaning (ES:0.50, P=.02). No adverse events were observed. Conclusion: This novel Ayurvedic whole systems, multimodal intervention was feasible and acceptable for BC survivors. Meaningful improvements were seen in QOL and clinical symptoms that warrant further investigation with a larger randomized controlled trial to assess causality.