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CTRI Number  CTRI/2024/11/076635 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Mind Body Medicine Program in Young Female Breast Cancer patients on sleep quality, quality of life and physiological and biochemical parameters 
Scientific Title of Study   Effectiveness of “Healthy Breast-Mind Body Medicine Program”(HB-MBMP) in addition to Standard Care in Young Female Breast Cancer patients on Sleep Quality, Circadian rhythm (HPA axis Regulation), QoL in a Tertiary Care Hospital in Rishikesh, Uttarakhand: An Open Label Double-arm Randomized Control Trial 
Trial Acronym  HB-MBMP Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vartika Saxena and Dr Farhanul Huda 
Designation  Professor 
Affiliation  AIIMS, Rishikesh 
Address  Department of CFM, AIIMS, Veerbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000294  
Fax    
Email  vartika.cfm@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vartika Saxena 
Designation  professor 
Affiliation  AIIMS, Rishikesh 
Address  Department of CFM, Veerbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000294  
Fax    
Email  vartika.cfm@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Vartika Saxena 
Designation  professor 
Affiliation  AIIMS, Rishikesh 
Address  Department of CFM, Veerbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000294  
Fax    
Email  vartika.cfm@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
CCRYN, 61-65 Institutional area, D-Block, Janakpuri, new Delhi- 110058 
 
Primary Sponsor  
Name  CCRYN 
Address  janakpuri, New Delhi 
Type of Sponsor  Research institution 
 
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 
Dr Vartika Saxena  Department of General Surgery, AIIMS, Rishikesh  Veerbhadra Road, Rishikesh
Dehradun
UTTARANCHAL 		 8475000294

vartika.cfm@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS, Rishikesh  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 
Intervention  HP-MBMP (Healthy Breast-Mind Body Medicine Program) & Standard care  “Healthy Breast MBM Program” (60 minutes)per day X 6 Months A. Annamaya Kosha 1. Diet counselling : Positive promotion of satwik diet 2. Sukshma Vyayama (loosening exercises) (seven minutes), 3. Asanas a. Tadasana (mountain pose) (two minutes), b. Kati Chakrasana (lateral arc pose) (two minutes), c. Padadhirasana (standing forward bend) (three minutes), d. Tiryaka Tadasana (swaying palm tree pose) (two minutes), e. Hridaya Mudra (heart gesture) (two minutes), f. Gomukhasana (cow face pose) (three minutes) 4. Jyoti Trataka (Yogic Visual Concentration) (twenty minutes) (Once a week) B. Pranamaya Kosha 5. Nadi Shodhana Pranayama (alternate-nostril breath) (three minutes), 6. Bhramari Pranayama (bee breath) (two minutes), 7. Ujjayi Pranayama (Ocean Breath), and 8. Shavasana (corpse) (five minutes) C. Manomaya Kosha 9. Yoga Nidra (eleven minutes) D. Vijyanmaya Kosha 10. Sleep education E. Anandamaya Kosha 11. Selflessness and service attitude • Validity of the program will be tested before application. • A chart will be provided for promoting the satwik diet. • A dairy will be provided for daily affirmative sentences & list out the positive action points for reinforcement of anandamaya kosha 
Comparator Agent  Standard care  Standard care 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  Young women aged 15-39 years’ patients diagnosed with histologically confirmed breast carcinoma with newly diagnosed cases with I – III stages.
Patients undergoing active treatment for breast carcinoma, including surgery, chemotherapy, radiation therapy, hormone therapy, or a combination of these treatments.
Patients with a ECOG score of 60 or above, indicating a reasonable ability to perform daily activities
Patients who can provide informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Patients with severe cognitive impairments or mental health conditions that may hinder their ability to participate in yoga sessions or complete study assessments
Patients with physical disabilities or musculoskeletal conditions that may prevent them from safely engaging in yoga practices
Patients with severe uncontrolled comorbidities (e.g., heart failure, chronic obstructive pulmonary disease) that may limit their ability to participate in yoga safely
Patients currently engaged in other mind-body practices or alternative therapies that may confound the study results
Patients with a history of prior yoga intervention for breast carcinoma within the past six months
Pregnant patients, as yoga practices may need to be modified during pregnancy, and hormonal changes during pregnancy can impact study outcomes
Patients not having access to smartphones and Internet connectivity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Sleep Quality (PSQI)  Day 0, Day 30, 3 month, 6 month/termination of trial 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0)  Day 0, Day 30, 3 month, 6 month/termination of trial 
Anxiety, Stress and Depression   Day 0, Day 30, 3 month, 6 month/termination of trial 
Positive and Negative Affect Schedule  Day 0, Day 30, 3 month, 6 month/termination of trial 
Salivary Cortisol  Day 0, 6 month/termination of trial 
Salivary DHEA  Day 0, 6 month/termination of trial 
ACTH  Day 0, 6 month/termination of trial 
CRH  Day 0, 6 month/termination of trial 
HRV  Day 0, 6 month/termination of trial 
Level of Lymphedema  Day 0, 6 month/termination of trial 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Adolescents and young women with breast cancer have special psychosocial issues such as concerns for effects on family life, personal life and career.  They face body related stigma, breast feeding related issues, education related issues. (3) Sleep disturbances are common symptoms in individuals with breast cancer. The incidence varies across studies depending on the study design and assessment methods, but most studies have reported that 60%–90% of patients with breast cancer have sleep disturbances—much higher than that in the healthy population. (4)

Yoga has a comprehensive approach towards the mind and body, giving a specific philosophical attitude towards life, with a meditative and attentional component as the basis for all its practices, thus being shown to have many psychophysiological effects, such as reducing anxiety levels and physiologic arousal; improving subjective sleep quality in patients with chronic insomnia; reducing both subjective and objective insomnia symptoms; and improving quality of life. Yoga and meditation are also inexpensive and side-effect–free interventions, which are well tolerated and used as integrative practices in non-drug treatments in many health-related contexts. Its therapeutic potential lies in promoting physical, emotional, and spiritual well-being, making it an attractive option for individuals dealing with the complexities of breast carcinoma. (5)

For holistic health all the five sheaths of our body (Pancha Kosha) namely Annamaya Kosha, Pranamaya Kosha, Manomaya Kosha, Vijyanmaya Kosha and Anandamaya Kosha are to be kept in good condition. Disturbance in one affects the other because these five sheaths function in coordination with each other to form an integral whole. It is important to awaken and strengthen these koshas as they provide the road map to lead us smoothly from our physiological; to psychological to spiritual self and thus help us live a healthy, happy and peaceful life.  
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