Rao, M.R., Raghuram, N., Nagendra, H.R., Gopinath, K.S., Srinath, B.S., Diwakar, R.B., . . . Varambally, S. (2009). Anxiolytic effects of a yoga program in early breast cancer patients undergoing conventional treatment: A randomized controlled trial. Complementary Therapies in Medicine, 17(1), 1–8.

To compare effects of a 24-week yoga program with those of a supportive therapy control intervention in patients with early breast cancer

Prior to surgery, patients were assessed and randomly assigned to the yoga program intervention or control condition. All patients received 50 cGy of radiation therapy over six weeks and were prescribed six cycles of standard chemotherapy with the same schedule. Patients in both groups received alpraxolam 0.5 mg once daily for one week following chemotherapy for the first one to two chemotherapy cycles. Patients in the yoga group had four in-person sessions during the perioperative period and were to undergo three in-person sessions per week for six weeks during radiotherapy treatment, with self-practice on the remaining days. During chemotherapy, patients had in-person sessions during visits (one per 21 days) and in-person sessions with a trainer every 10 days. The instructor monitored self-practice through telephone calls and house visits. The control intervention was brief supportive therapy with education, including 15-minute counseling sessions every 10 days during treatment by a social worker. All patients were asked to maintain daily diaries of symptoms, medication, and diet intake, and for those in the yoga group, their frequency and duration of yoga practice.

• The study reported on a sample of 38 female patients.
• Age information was not reported.
• All patients had early-stage breast cancer, and 51% were postmenopausal.
• Of the total sample, 28% reported having other stressful life events in the past two years.

• Single site
• Inpatient and outpatient setting
• India

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

• State-Trait Anxiety Inventory: symptom grading on 0–4 Likert-type scale
• Patient diary

Sixty-one percent of patients initially randomized dropped out of the study. Approximately half of these patients decided to leave the study after initial surgery, and the rest of the dropouts were removed from the study because they did not end up receiving the same expected adjuvant treatment sequence. Anxiety declined over time in all patients, and overall ANOVA did not show a significant group and time effect. Post hoc analysis showed that the yoga group had significantly lower anxiety immediately postsurgery and midway through radiation therapy (p < 0.05) and midway through chemotherapy (p < 0.001). Analysis of overall symptom distress showed a significant effect of the yoga group over time for reduction in symptom distress (p = 0.001). Post hoc testing showed a significant decrease in trait anxiety in the yoga group compared to controls at several time points in the study (p < 0.01). The effect size for state anxiety was 0.33. Anxiety and symptom distress were strongly correlated at all phases of treatment, with r ranging from 0.49 to 0.73 (p < 0.05).

Anxiety decreased over time in all patients. The yoga intervention was associated with a significantly greater reduction in anxiety at several time points in the treatment schedule, immediately following surgery, midway through radiation therapy, and midway through chemotherapy.

• The study had a small sample size, with less than 100 participants. Although small, the sample size was based on power analysis, but assumed a larger anxiety effect size than found in this study.
• The study had a very high drop-out rate. Intention to treat analysis was done using baseline measures for dropouts, resulting in much less change in outcomes seen, which was not particularly helpful in attempting to evaluate the effects of participation in the intervention. The control condition did provide some patient attention, but it was much less than that received by the intervention group.
• The study did not include information regarding actual patient adherence to self-directed yoga practice.
• Potential risk of bias exists due to no blinding.

Yoga as provided in this study, with individual instructor-directed sessions and patient self-guided practice expectations, had a mild effect in reducing anxiety over time during various phases of cancer treatment. Guided sessions were done at scheduled visits for treatment, suggesting that this can be a practical way to facilitate patient participation. Patients may find yoga helpful to reduce stress and anxiety.