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| MANN KI BAAT - SPL. ISSUE - SECTION 4: SECTION 4: YOGA & SWASTHAVRITTA (LIFESTYLE, EXERCISE, FOOD, NUTRITION) |
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| Year : 2023 | Volume
: 7
| Issue : 5 | Page : 36-37 |
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Tata Memorial Centre's largest randomized trial testing the effect of Yoga on Breast Cancer
Rajendra A Badwe1, Nishu Singh Goel2
1 Director, Tata Memorial Hospital, Department of Surgery, Mumbai, Maharashtra, India
2 Yoga Expert, Chief Department of Kewat, Tata Memorial Hospital, Mumbai, Maharashtra, India
| Date of Submission | 15-Apr-2023 |
| Date of Acceptance | 18-Apr-2023 |
| Date of Web Publication | 28-Apr-2023 |
Correspondence Address:
Rajendra A Badwe
Tata Memorial Hospital, Department of Surgery, Dr. E Borges Road, Parel Mumbai 400 012, Maharashtra
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_99_23
How to cite this article:
Badwe RA, Goel NS. Tata Memorial Centre's largest randomized trial testing the effect of Yoga on Breast Cancer. J Res Ayurvedic Sci 2023;7, Suppl S1:36-7 |
How to cite this URL:
Badwe RA, Goel NS. Tata Memorial Centre's largest randomized trial testing the effect of Yoga on Breast Cancer. J Res Ayurvedic Sci [serial online] 2023 [cited 2023 Jun 8];7, Suppl S1:36-7. Available from: http://www.jrasccras.com/text.asp?2023/7/5/36/374519 |
Do not look at Ayurveda and Yoga as a means of medical treatment only; instead of this, we should make them a part of our life.
- Hon'ble Prime Minister Shri Narendra D. Modi
(Mann Ki Baat, 29 Oct, 2017)
In the 96th episode of Mann Ki Baat (MKB) on 25.12.2022, Hon'ble Prime Minister (PM) of India, Shri Narendra D. Modi stated that- 'Satyam kim pramanam, pratyaksham kim pramanam'. i.e., 'Truth does not require proof; what is evident also does not require proof.' However, he cautioned that 'Evidence' is of prime importance in the context of medical science. He lauded the efforts of our Tata Memorial Centre (TMC) for generating 'Evidence' of the effectiveness of Yoga in breast cancer patients.
‘Evidence-based and affordable cancer care’ has always been a motto for our service to countrymen who have cancer. Evidence from well-conducted research will be discussed for its robustness and applicability across urban, semi-urban and rural India. If so, it will be adopted as guidelines, if cost-effective. Innovation would not only be in the well-trodden roads of genomics, proteomics, metabolomics, and stem cells with its associated molecular technology but also in less explored avenues of herbal medicine. At TMC, we believe in the potential of traditional Indian systems of medicine like Ayurveda and Yoga; however, as mentioned by Honourable PM, there is a need for evidence for its use in cancer patients.
“All of you must have heard about the Tata Memorial Center in Mumbai. This institute has earned a name for itself in Research, Innovation, and Cancer care. Intensive research done by this center has revealed that Yoga as an adjunct to standard care is very effective for breast cancer patients. Tata Memorial Center has presented the results of its research at the very prestigious Breast cancer conference held in America. These results have attracted the attention of the world’s biggest experts, as Tata Memorial Center has shown how patients have benefited from Yoga. According to this center's research, regular yoga practice has reduced the risk of recurrence and death of breast cancer patients by 15 percent. It is the first example of Indian traditional medicine being tested vis a vis the stringent standards of Western methods. Also, this is the first study in which Yoga has been found to improve the quality of life in women affected by breast cancer. Its long-term benefits have also come to the fore. The Tata Memorial Center has presented the results of its study at the European Society of Medical Oncology conference in Paris.”(Mann ki Baat 25 Dec, 2022)
As we know, 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.
The yoga intervention was carefully designed with inputs from yoga consultants, clinicians, and physiotherapists to suit the needs of breast cancer patients and survivors, keeping in focus the different phases of their treatment and recovery. The Yoga protocol included gentle and restorative Yoga postures (Asana) with regular periods of relaxation and pranayama. It was implemented through classes by qualified and experienced Yoga instructors. Additionally, the protocol’s handouts and CDs were provided to maintain compliance.
We randomized Women with non-metastatic BC during and after standard treatment 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), and 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.
Of the 850 women randomized to the study, 426 were on the YCE arm, and 424 were on the CE arm. The median age (47 vs. 48 years), median pT size (3 vs. 2.85 cm), grade 3 (82.7 vs. 82.1%), hormone receptor-positive (69% vs. 69.4%), and HER2neu positive (14.4 vs13.7%) were in YCE and CE arms respectively. At a median follow-up of 80 months, the disease-free 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 (<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 fatigue score 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 median baseline scores of fatigue severity 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 two years and then sustained till four 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 the YCE group was less than in the CE group, with a specific reduction in pain over the breast/ chest wall (p=0.018 at 24 mo). Lastly, SQ assessed spirituality and showed no difference, but less deterioration than baseline scores was noted in YCE. Fifty-three percent of women on YCE showed an improvement in QoL from baseline compared to 47% in CE. This cohort had 61% compliance to Yoga and physiotherapy in YCE, with 91.75% compliance among those who did Yoga for 6-9 mo and 85% to physiotherapy alone in CE.
Yoga resulted in a 15% relative improvement in DFS and 14% in OS. This trial did not reach statistical significance since the study was planned to look for a 25% difference and was not powered to detect a 15% improvement. It 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. 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.
Dr. Nita Nair presented in a SPOTLIGHT paper, the results of this landmark breast cancer study testing effect of YOGA, as SPOTLIGHT presentation at the San Antonio Breast Cancer Symposium (SABCS), one of the most prestigious breast cancer conferences in the world held annually in USA[1]. Of thousands of research papers submitted to the conference, few were chosen for spotlight discussion. Our study deserved this due to the novelty of intervention and the first very Indian intervention impacting outcomes in breast cancer.
The largest clinical trial is an essential milestone in using Yoga in breast cancer since this is the first example of a very Indian traditional remedy being tested in a rigorous Western randomized study design with a robust sample size. Breast cancer is the most common cancer affecting women in India and globally. It raises a considerable amount of anxiety in women two fold: the first fear of cancer with a threat to life and the second worry due to side effects of treatment and coping with it. It is heartening to see that Yoga practiced with rigor and perseverance has proved its superiority in maintaining an excellent quality of life and has also numerically reduced the risk of recurrence and death by 15%.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | |  |
| 1. | Nair Nita S, 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.  |
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