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Randomized controlled trial to evaluate the impact of yoga on QOL is also powered to evaluate the impact of yoga on survival. Study involves various phases of yoga(divided in three phases: Phase I/II/III) during treatment and survivorship, with a comparative analysis of different time points and the response to yoga, which will help integrating yoga as a complementary modality. Also, this study will help identify the long term and short term effects of this therapy in breast cancer patients and survivors.
One of the main differences between yoga and other forms of physical activity is that yoga exercises oppose violent muscle movement and is designed to counteract fatigue through relaxation and breathing. 6 monthly Follow Up will be for 5 years followed by yearly follow up.
Women with breast cancer are constantly exploring measures in addition to ongoing conventional therapy to relieve disease related symptoms, minimize side effects associated with conventional treatment, reduce their risk of recurrence and enhance their prospects for survival. Breast cancer survival rates have considerably improved over the years with the advent of new therapeutic measures and early detection. However its treatment sequelae are associated with significant changes in quality of life (QOL) and well being. Fatigue is one of the most prevalent QOL concerns, affecting 30% to 70% of breast cancer survivors.
Yoga is based on the practice of physical postures, breathing techniques and meditation. Philosophically, it aims at increasing the body's ability to master the mind with the goal of spiritual awareness and connection. A randomized trial of yoga in women with breast cancer undergoing radiation therapy demonstrated an improvement in impact of events scale at 3 months suggesting that the more intrusive thoughts at 1 month the greater the finding of meaning in cancer by 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise I | Experimental | Yogic and Routine Exercises (referred to as exercise I) Phase I: 1-7 days (Minimum attendance 4 days), Phase II: 8 - 14 days (Minimum attendance 4 days), Phase III: at 6-9 months or 12-15 months 1 year up gradation of exercises at 6-9 month or 12-15 months 1 year (Depending upon compliance to phase II exercises) Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months Exercise evaluation will be done at 6-9, 12-15, 30-33, 48-51 and 66-69 months |
|
| Exercise II | Active Comparator | Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga Exercises | Other | The exercises in the Exercise I arm (Yoga and conventional exercises) will be upgraded to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I and II. Patients will be assessed at 6-9 months for compliance to phase II exercises. Only if patients are fulfilling the criteria for accuracy, sequence and duration of phase II exercises, will they be taught phase III exercises. Patients who are unable to do phase II exercises accurately or demonstrate non compliance to the exercise routine at first follow up visit/ 6-9 months will be re taught phase II exercises. These patients will be upgraded to phase III only if able to perform phase II adequately at assessment. Six months after completion of phase III exercises, patients will be assessed for compliance to phase III exercises. These women's will be assessed at the subsequent 6-9 month follow up and compliance will be evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | To assess the effect of yoga on disease free survival in women breast cancer. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the impact of Yoga on inflammatory cytokines and cell free chromatin | The impact of yoga on inflammatory markers will be assessed by using serum samples to check the concentration of IL2, TNF alpha, IL6, IL8, IL10 and C reactive protein by using ELISA technique. | From randomization to 12 months |
| Pain assessment |
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Inclusion Criteria:
Exclusion Criteria:
Womens with breast Cancer
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| Name | Affiliation | Role |
|---|---|---|
| nita nair, Mch | Tata Memorial Centre | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15923576 | Background | Knols R, Aaronson NK, Uebelhart D, Fransen J, Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. J Clin Oncol. 2005 Jun 1;23(16):3830-42. doi: 10.1200/JCO.2005.02.148. | |
| 16773438 | Background | Lemieux J, Topp A, Chappell H, Ennis M, Goodwin PJ. Economic analysis of psychosocial group therapy in women with metastatic breast cancer. Breast Cancer Res Treat. 2006 Nov;100(2):183-90. doi: 10.1007/s10549-006-9249-1. Epub 2006 Jun 14. |
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Arm I: Yoga & Conventional Exercises Arm II: Conventional Exercises All eligible patients will be randomly to either of the arm as mentioned above.
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To assess the effect of yoga using Pain Assessment chart questionnaire, having score scale from scale 0 to 10 wherein 0 represent "No Pain" and 10 represent "Worst Possible Pain" |
| from randomization to 60 months |
| Quality of life assessment | To assess the effect of yoga using Quality of life questionnaire (QLQ-30, BR-23, Spirituality & BFI having score scale from 1-4, wherein 1 represents 'Not at All' and 4 'very much' | from randomization to 60 months |
| Improvements in Lung Function | To assess the effect of yoga in improving the Lung Function by evaluating Pulmonary Function Teast (PFT) readings. | The FEV1/ FVC ratio and the value will be checked, if the value is within 80% to 120%, it will be considered as normal (95 percent confidence interval). From randomization until 12 months. |
| Improvements in Overall survival | To assess the effect of yoga on overall free survival in women breast cancer. | from the date of randomization to the date of death or censored at the date of last follow up for the patients who are alive or lost to follow up, until 60 months |
| 23213072 | Background | Jones SB, Thomas GA, Hesselsweet SD, Alvarez-Reeves M, Yu H, Irwin ML. Effect of exercise on markers of inflammation in breast cancer survivors: the Yale exercise and survivorship study. Cancer Prev Res (Phila). 2013 Feb;6(2):109-18. doi: 10.1158/1940-6207.CAPR-12-0278. Epub 2012 Dec 4. |
| Background | L. Cohen, K. D. Chandwani, G. Perkins, B. Thornton, B. Arun, N. V. Raghuram, H. R. Nagendra Randomized trial of yoga in women with breast cancer. Undergoing radiation treatment: Long-term effects. J Clin Oncol 26: 2008 (May 20 suppl; abstr 9639). |
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