A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer - A Randomized Pilot Study
Phase: NA
Conditions: Prostate Carcinoma
Sponsor: Emory University

A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer – 
A Randomized Pilot Study 
NCT03220945 
 
 
Study Protocol and Statistical Analysis Plan 
Document Date: March 6, 2017 
 
 
Principal Investigator: 
Omer Kucuk, MD 
 
Co-Investigators: 
Alicia K. Smith, PhD; Ashesh B. Jani, MD, PhD; Peter J. Rossi, MD 

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A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer – 
A Randomized Pilot Study
Principal Investigator: 
Omer Kucuk, MD 
Co-Investigators: 
Alicia K. Smith, PhD; Ashesh B. Jani, MD, PhD; Peter J. Rossi, MD
Background and Significance
A rapidly growing body of research now robustly links psychological and behavioral factors 
to physiological parameters and to the incidence and biology of a broad spectrum of diseases, 
ranging from coronary heart disease, to asthma. HIV-1 infection, and cancer (e.g. Levy et al., 1987; 
Redd et al., 1991; Kiecolt-Glaser et al., 2002; Antoni, 2003). For example, evidence exists which 
links psychological factors to the incidence and progression of cancer (Lewis et al., 2002; Thomas 
et al., 2002). 
It is known that being diagnosed with cancer and receiving treatment is associated with high 
emotional distress that lowers psychological and physiological wellbeing (Patrick et al., 2003). 
Cancer patients commonly experience pain, anxiety, depression, and fatigue which often continue 
even after the end of treatment (e.g. Patrick et al., 2003; Kangas et al., 2008). There is thus a need 
for research to find the treatments that best can address such symptoms.
Psychosocial stress has also been suggested to potentiate cancer development and possibly 
tumor progression by promoting alterations in normal DNA repair capabilities (e.g. Kiecolt-Glaser 
et al., 2002). Chronic distress, such as having a chronically ill child, or caring for a relative with a 
life threatening disease, has been shown to lead to shortened telomeres and thereby possibly 
promote earlier onset of age-related diseases (Epel et al 2004). These and other findings suggest 
that psychosocial stress can affect physiological parameters which in turn can affect quality of life 
as well as disease progression/outcome in cancer patients. Consistently, a life-style change program 
that included diet, exercise, and stress reduction methods had favorable effects in PCa and breast 
cancer patients in terms of clinical events, cancer related gene expression, telomerase levels and 
activity, and biochemical markers (e.g. Ornish et al., 2008, 2013). 
The findings summarized above have been the rationale for the use of psychosocial 
interventions in the rehabilitation of cancer. Recent meta-analysis findings suggest that 
psychosocial treatment can be effective in improving quality of life parameters after primary cancer 
treatment (Fors et al., 2010). Furthermore, psychosocial support treatment decreased disease 
recurrence and increased life expectancy in a cohort of cancer survivors (n=227, 11-year followup) 
(Andersen et al., 2008). In a study involving both PCa and breast cancer patients, a mindfullness 
based program enhanced quality of life and decreased stress symptoms, altered cortisol and immune 
patterns consistent with less stress and mood disturbance (Carlson et al., 2007). In addition, it was 
also shown in a randomized clinical trial that chronic inflammation, negative mood, and fatigue 
were alleviated by a yoga based program in breast cancer survivors (Kiecolt-Glaser et al., 2014). 
Similarly, another randomized trial showed that a yoga program improved quality of life and 
physiological effects associated with radiotherapy in breast cancer survivors (Chandwani et al., 
2014).
Prostate cancer (PCa) is the most prevalent cancer in men (Desantis et al., 2014). PCa has the 
highest Medicare expenditure than any other cancer that affects older men. Modern tailored 

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treatment regimens have resulted in longer life expectancy, but also longer treatment periods, which 
lead to treatment related morbidity, as well as adverse side effects, including psychological distress 
and pain (e.g. Penson and Chan, 2007; Bhoojani et al., 2008)). For example, depression has serious 
implications for outcomes and recovery from PCa as reflected in debilitating effects on health 
related quality of life, functional status, health resource utilization and cost (Bhoojani et al., 2008; 
Pirl et al., 2008; Reeve et al., 2009, Weber et al., 2008). Consistently, a recent National Cancer 
Institute based evaluation recommended four patient-reported outcomes to be routinely 
incorporated into clinical trials: pain, fatigue, mental well-being, and physical well-being (Chen et 
al., 2014).
As indicated in some of the examples above, many patients with cancer turn to integrative 
medicine (IM) modalities to help manage their symptoms (for a review, see Dobos et al., 2013). In 
addition to best standard of care from western perspective, IM  encompasses a broad array of 
heterogeneous treatments, ranging from herbal medicine to yoga. Yoga has recently undergone 
empirical investigation, as exemplified above, as a potentially beneficial intervention for patients 
with cancer. An ancient Eastern tradition estimated to be a 5000-year-old discipline originating 
from India (Udapa and Singh, 1972), a yoga program encompasses various domains, including 
ethical disciplines (e.g. non-harm in actions and words), physical postures (asanas), and spiritual 
practices, with the goal of uniting the mind, body, and spirit for health and self-awareness. Hatha-
yoga, the classical form of yoga, is considered to improve bodily functions through the 
manipulation of cardiovascular, respiratory, metabolic, and other control mechanisms. Whereas 
asanas are generally familiar, the pranayama, the breathing practices, and the central role that they 
have in yoga, are not usually sufficiently emphasized. 
One of the most widely used breathing techniques derived from yoga is Sudarshan Kriya 
(SK) (Murthy et al, 1998; Janakiramaiah et al., 2000) that is used in conjunction with other central 
aspects of yoga. SK is traditionally understood to use specific rhythms of the breath to eliminate 
stress, support the various organs and systems within the body, transform overpowering emotions 
and restore peace of mind. Recent medical research on SK and related practices (SK&P), also 
referred to as SK yoga or SKY, has indicated significant effects on various aspects of the 
physiology and the psychology of the participants. 
For example, studies demonstrated that SKY has important antidepressant effects in clinical 
settings (Murthy et al, 1998; Janakiramaiah et al., 2000) and is comparable to the antidepressant 
drug Imipramine in its efficacy. Effect of SKY on psychological health is not limited to clinical 
patients. Saatcioglu and co-workers conducted a controlled study and found that participants in the 
SKY group, but not the control group, significantly lowered their degree of anxiety, depression and 
stress, and also increased their degree of optimism (Kjellgren et al., 2007).
Another study found significantly lower levels of blood lactate in practitioners of SKY 
compared with the control group. Conversely, the levels of superoxide dismutase (SOD), catalase, 
and glutathione, three major defenses against oxidative stress, were all found to be significantly 
higher in SKY practitioners compared with the control group (Sharma et al., 2003). These data 
suggest that people who practice SKY have an improved antioxidant status and defense against 
oxidative stress.
Various additional studies indicate that SKY results in improved physical and psychological 
health. For example, there are interesting findings on the effects of SKY on brain function, 
indicative of a state of wakeful alertness (Bhatia et al., 2003). In addition, there appears to be 
strengthening of the immune system, as measured by increases in natural killer (NK) cell number, 
in both healthy people, but also in cancer patients (Kochupillai et al., 2005). Furthermore, SKY has 
been shown to be effective in post-traumatic stress disorder (Carter et al., 2013) and in a 
randomized trial Saatcioglu and co-workers found that it affected the circulating immune cells at 
the level of gene expression (Qu et al., 2013). 
The goal of this proposal is to systematically study the possible impact of SKY on PCa 
patients. The studies will include not only psychological assessment through self-report 
questionnaires on pain, fatigue and psychological well-being, but also objective measures on basic 
physiological parameters, including the stress hormone cortisol and cytokine IL-6. Our hypothesis 
is that there would be a measurable effect of SKY on psychological distress in PCa patients on the 

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parameters to be tested, and that this will correlate with favorable changes in physiological 
parameters that may impact disease progression. 
Our preliminary data from two clinical trials we conducted in students (Kjellgren et al, 
2007) and healthy volunteers (Qu et al, 2013) support our hypothesis (see above, studies by 
Saatcioglu and co-workers, as referenced in Kjellgren and Qu papers). There was decreased 
anxiety, depression and stress in one study, and improved physiologic changes in the other. These 
preliminary results give us confidence that the proposed study will showed the hypothesized 
improvements in the health status and physiological parameters of patients with PCa.
Specific Aims:
This study will have two parts:
1. Determine any change in pain, fatigue and psychological well-being as a result of SKY in 
PCa patients.
2. Assess changes in some physiological parameters in response to SKY in the same subjects, 
compare these with those from Part 1, and assess whether these translate into clinical 
effects.
Subjects:
PCa patients that have been treated with radiotherapy will be recruited to the study (Winship 
Cancer Institute Clinic, contact person Dr. Omer Kucuk). 
Inclusion criteria: Age >= 45 years; having finished radiotherapy at least two months ago; 
ability to speak/read English and give informed consent; having an interest in being part of a study 
to evaluate yoga-derived exercises and eager to practice some kind of relaxation exercise daily for 3 
months. 
Exclusion criteria: Having a diagnosis of psychiatric illness or other major illness in addition 
to PCa, such as other cancers, uncontrolled hypertension, lung disease, liver disease or heart 
disease. 
Approval by the IRB Committee will be applied for. All participants will sign consent forms 
and throughout the study they will be treated according to the ethical guidelines, in addition to 
standard treatment for PCa. Participants will be informed that the data obtained in this study will be 
kept in a separate approved password controlled secure database at the Winship Cancer Institute of 
Emory University, and that the data from this database will be linked to the approved clinical 
database in the same institution. They will also be told that they participate by their free will and 
that they are free to leave the study whenever they wish without giving any reason for it and not 
risking any consequence for the standard treatment that they will receive.
The men will be randomly assigned to one of two groups: 
1.
No treatment control.
2.
Healing Breath Program (SKY).
SKY includes gentle stretches (yoga postures), specific breathing exercises (see below), and 
cognitive coping and stressor evaluation strategies. SKY is traditionally understood to dissolve 
emotional distress and create the subjective experience of rest and well-being. The instructors in 
SKY are trained by the International Art of Living Foundation. The yoga intervention is held over 
13 weeks: in Week 1, subjects will receive yoga instruction for approximately 3 hours daily on 5 
consecutive weekdays, and in Weeks 2-13, subjects will attend yoga instruction once a week for 
about 2 hours. 
The breathing techniques that are part of SKY are: (a) Three-Stage Pranayama with Ujjayi or 
"Victory Breath", (b) three sets of Bhastrika or "Bellow's Breath", and (c) SK, and they are 
practiced in that order. The breathing practices are done in a sitting posture, either in a chair or on 
the floor. Eyes are kept closed throughout the sessions. 
A total of 50 patients will be randomized into the two study arms. 20 subjects are aimed at in 
each group, but to account for drop-out/exclusion, 25 subjects will be recruited per group (to 
accommodate drop-out/exclusion rate of 20%). Both groups will be tested at the time of recruitment 

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to the study as Pretest 1. The SKY intervention will be given in groups of 10-15 patients and the 
tests will be performed again within 2 weeks of the first week of yoga (Posttest 1). The control 
group will be tested at the same time.  Posttest 2 will be performed within 2 weeks of completing 
the 13-week yoga program, using the same parameters. In addition to daily home practice, there 
will be weekly follow-up sessions for the SKY group which will last about 2 hours during which 
exercises will be performed in a group and questions that may arise related to the practice will be 
answered. Control subjects will be offered 1-week of yoga classes after the end of the study (ie, 
after post-test-2)
Below is a brief flowchart of the study timeline:
Week -- 
Recruitment (3 months prior to the start of yoga)
Week -- 
Pretest 1 (within 2 months prior to starting yoga)
Week 1-13 
SKY intervention (13 weeks)
Week 2-3 
Posttest 1 (within 2 weeks of the first week of yoga)
Week 14-15 
Posttest 2 (within 2 weeks of the last week of yoga)
Research design and methods:
Aim 1. Determine any change in pain, fatigue and psychological well-being as a result of SKY 
in PCa patients.
We will assess psychological wellness parameters in the PCa subjects at the time points as 
described above. This will be done by administering standardized questionnaires which are 
enumerated below:
1.
The Hospital Anxiety and Depression Scale (HADS): A 14-item self-rating scale, 
measuring anxiety and depression (Zigmond and Snaith, 1983).
2.
The EORTC Quality-of-life Questionnaire (EORTC QLQ-C30). A cancer-speciﬁc 30-item 
questionnaire (Aaronson et al., 1993) incorporating 5-functioning scales, a global health-
status/QOL scale and symptoms assessment. In addition Functional Assessment 
of Cancer Therapy-Prostate (FACT-P) questionnaire will be utilized.
3.
The Life Orientation Test – Revised (LOT-R): A 10-item self-report scale, measuring 
expectations about positive outcome in general (Scheier et al., 1994) 
4.
36-item short-form health survey (SF-36) vitality scale, a reliable and valid measure of 
energy/fatigue in the past month (Stein et al., 1998).
5.
Pain will be assessed with the BPI-SF questionnaire (Cleeland and Ryan, 1994).
Aim 2. Assess changes in some physiological parameters in response to SKY.
In addition to the self-report measures described above, it is important to use objective 
measures to determine if SKY practice results in physiological effects. As reviewed above, previous 
studies on SKY have indicated various physiological effects, such as positive influence on the 
immune system, support of the antioxidants system, and effects of gene expression in the 
circulating immune cells. To evaluate if similar effects are observed in PCa patients, and whether 
these correlate with the measures in Part 1, venous blood, saliva, and hair will be collected at the 
three time points and the following tests will be performed:
1.
Enzymes indicative of antioxidant status, i.e. Superoxide Dismutase (SOD) and Glutathione 
peroxidase (GPX) (based on previous studies by Sharma et al., 2003). We will also measure 
serum 8-isoprostane level, an indicator of oxidative stress.
2.
Inflammatory markers, i.e. Interleukin 1 and 6, Tumor Necrosis Factor alpha (TNF), and 
C-reactive protein (since these cytokines are important in carcinogenesis and may be 
modulated by psychosocial intervention therapies).
3.
Saliva cortisol taken between 07 and 09 am, as measure of psychophysiological stress 
(Levine et al., 2007).

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4.
Hair cortisol, using a 1-inch strand of hair taken from the back of the head, as a measure of 
psychophysiological stress. 
In addition, two epigenetic tests will be performed:
5.
RNA will be isolated from the peripheral blood mononuclear cells (PBMCs) and gene 
expression changes will be assessed as previously done in response to the SKY regimen 
(Qu et al., 2013).
6.
DNA will be isolated from the PBMCs and potential DNA methylation changes in response 
to SKY regimen.
The levels of these endpoints (1-3) and gene expression profiles will be compared during the 
different time points as described above. 
STUDY FLOW CHART:
Yoga group:
1.
Prestudy evaluations: Questionnaires, and blood/saliva/hair samples (within 2 months 
prior to starting Yoga instructions)(Pre-test 1)
2.
Yoga instructions
    Week 1 – Yoga instruction (3 hours daily for 5 days)
       Week 2-13 –Yoga instruction (2 hours on one day each week)
3.
Post-study evaluations (1): Questionnaires, and blood/saliva/hair samples (within 2 
weeks of the first week of yoga)(Post-test 1) (Week 2-3)
4.
Post-study evaluations (2): Questionnaires, and blood/saliva/hair samples (within 2 
weeks of the last week of yoga)(Post-test 2) (Week 14-15)
Control group:
1)
Prestudy evaluations: Questionnaires, and blood/saliva/hair samples (after consenting) 
(Pre-test 1)
2)
Post-study evaluations (1): Questionnaires, and blood/saliva/hair samples (within 6-8 
weeks from the pre-test 1 evaluations)(Post-test 1)
3)
Post-study evaluations (2): Questionnaires, and blood/saliva/hair samples (within 2-4 
months after Post-test 1 evaluations)(Post-test 2)
4)
Control subjects will be offered 1-week of yoga classes after the end of the study (ie, 
after post-test-2)
Statistical Considerations:
Fifty subjects should be a sufficient sample size because in our previous study with a sample size of 
14 subjects we were able to observe statistically significant changes (Qu et al, 2013). Comparisons 
will be made with the Student's t test. A value of P<0.05 will indicate statistical significance. 
Research team: 
The main coordinator of the project is Dr. Omer Kucuk, Department of Hematology and Medical 
Oncology, Emory University. The collaborator partners are: Alicia Smith, PhD, Department of 
Psychiatry; Dr. Ashesh Jani, and Dr. Peter Rossi from Department of Radiation Oncology, Emory 
University.
Yoga instructions will be provided by Art of Living Center instructors in Atlanta. They have 
agreed to provide the SKY intervention proposed in this study.
Epigenetic, biochemical and inflammatory marker laboratory tests will be done at Dr. Alicia 
Smith’s Laboratory. Prof. Saatcioglu has conducted research using similar methodology (testing of 
wellness parameters, cancer related endpoints, and gene expression) (Kjellgren et al., 2007; Qu et 
al., 2013) which will facilitate the current work.
Ethical considerations: All work will be done in accordance with the ethical principles of human 
subject use and the rules of the Institutional Review Board (IRB) at Emory University. All 

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members of the research team have participated in similar studies before involving human subjects 
and are thus familiar with all the procedures that are necessary. 

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Detailed 1-year Budget (see attached Excel file)
$12,650 study coordinator/nurse/data manager fee
$4000 SKY instruction and followup (4x16 hr instruction and 24x3 h for followup) 
$1500 IRB fee
$3350 Biochemical tests
$4000 Inflammatory biomarkers
$4500 Pilot epigenetic studies
TOTAL: $30,000
Budget Justification
Study coordinator (25% effort) will help with subject recruitment, consenting, enrollment 
on study, follow-up and conduct of the study according to protocol and collecting data and 
keeping study CRF’s and records.
$12,650
SKY instructors from Art of Living Center (Atlanta) will provide yoga instruction to 
study subjects.
$4,000
Biomarker studies (epigenetic, biochemical, inflammatory markers) will be done at Dr. 
Alicia Smith’s laboratory.
$11,850
IRB fee
$1,500