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CTRI Number  CTRI/2020/09/027758 [Registered on: 11/09/2020] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   "Effect of Yoga in Breast Cancer Patients". 
Scientific Title of Study   "Effect of Yoga on serum inflammatory biomarkers, psychophysiological and Quality of Life Indicators in Breast Cancer Patients". 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajashekar Mohan 
Designation  Professor and Head Department of Surgery. 
Affiliation  KS Hegde Medical Academy (Deemed to be University) 
Address  Justice KS Hegde Charitable Hospital Deralakatte Karnataka
Deralakatte Mangaluru-575018 Karnataka
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845806323  
Fax    
Email  rajshekarm@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Fatima Dsilva 
Designation  Professor 
Affiliation  Nitte Usha Institute of Nursing Sciences 
Address  Nitte Usha Institute of Nursing Sciences Paneer Deralakatte Mangaluru
Paneer Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9980645781  
Fax  08242203160  
Email  ftds_1970@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Fatima Dsilva 
Designation  Professor 
Affiliation  Nitte Usha Institute of Nursing Sciences 
Address  Nitte Usha Institute of Nursing Sciences Paneer Deralakatte Mangaluru
Paneer Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9980645781  
Fax  08242203160  
Email  ftds_1970@rediffmail.com  
 
Source of Monetary or Material Support  
Justice KS Hegde Charitable Hospital, Deralakatte, Mangalore 
 
Primary Sponsor  
Name  Dr Rajashekar Mohan 
Address  Justice KS Hegde Charitable Hospital Deralakatte Mangaluru 
Type of Sponsor  Other [Self funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kaini Cecilia  Justice KS Hegde Charitable Hospital  Department of Oncology and Department Surgery.
Dakshina Kannada
KARNATAKA 		 08722778848
08242203160
kainicecilia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee Nitte University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Regular conventional treatment.  No treatment will be administered,accept the regular conventional treatment. 
Intervention  Yoga  Category: Voluntarily Regulated Breathing. Objective: - To reduce depression - To reduce stress and anxiety - To improve breathing pattern - For coping up with the treatment and to enhance the mood. Practice: - Breath awareness - Yogic breathing - Alternate nostril breathing - Brahmari Pranayama - Sheethali Pranayama Duration: 10-12 minutes Category: Breathing Exercise with body movement. Objective: - To reduce breathlessness - To reduce the hospital stay - To improve range of motion. Practice: - Hands in, and out breathing - Hands stretch breathing - Ankle stretch breathing - Setubandhasana breathing - Lumbar stretch - Bhujangasana breathing Duration: 10-12 minutes Category: Relaxation. Objective: - To reduce the fatigue - To improve sleep hygiene Practice: - Progressive Relaxation Duration: 10-12 minutes Total Duration of Yoga: - 30 to 36 mins per day for 5 days in a week for 12 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Women diagnosed with breast cancer – stage II, III & IV
Age group of 18 to 80 years.
Breast cancer patients able to perform the yoga intervention.
 
 
ExclusionCriteria 
Details  Critically ill & debilitated breast cancer patients.
Breast cancer patients with inflammatory diseases.
Breast cancer patients unable process information.
Prior practice of Yoga in the last 6 month.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved inflammatory status, Psychophysiological and quality of life indicators.  6th month, 9th month. 
 
Secondary Outcome  
Outcome  TimePoints 
- Absence of inflammation
- Absence of Anxiety and depression
- Stable Physiological parameters
- Stable quality of life 		 12th month 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2020 
Date of Study Completion (India) 05/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

What is known about the problem?

Breast cancer is the most frequent cancer among women. According to WHO over 2 million new cases of breast cancer were reported in 2018 with, 627,000 deaths attributed to it. Every year1.5 lakh new cases of breast cancer are diagnosed in India. Cancer is as a source of stress, often leading to suffering, which is long-lasting. These stress related symptoms when left untreated or inadequately controlled, have a significant impact on emotional function, feelings of isolation, depression and anxiety. All these have a negative influence on healing, and adversely effects medical treatment compliance and health care utilization. Several complementary therapies are used in cancer management as an adjunct to conventional therapy to improve the overall quality of life. Among these, yoga is one of the most popular complementary therapy currently used by cancer patients.

Yoga is a group of physical, mental, and spiritual disciplines which originated in ancient India. Traditionally, yoga is known to ease anxiety, alleviate depression and improves quality of sleep, Yoga is a recommended intervention to improve psychological health during breast cancer treatment. Current research suggest that yoga modulates neural, hormonal, and immune functions at a cellular level, suggesting that yoga is a viable intervention to reduce inflammation across a multitude of conditions.

 

Specific Research Lacuna being address:

Yoga has its positive impacts on depression, anxiety, pain and quality of life. However, there is lack of objective evidence of yoga’s positive impact and its molecular mechanism in cancer patients.

Significance of proposed Research:

Yoga breathing is a feasible intervention among patients receiving chemotherapy,Yoga interventions are cost effective, and validating the effects of yoga on various cancer progression pathways and correlating these with psychophysiological and quality of life indicators is the need of the hour. A positive correlation would prove Yoga to be a priceless intervention not only as an adjunct treatment but also to optimize recovery in breast cancer patients.

 
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