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CTRI Number  CTRI/2024/12/078322 [Registered on: 19/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The impact of cardio-oncology rehabilitation in breast cancer patients 
Scientific Title of Study   The impact of cardio-oncology rehabilitation on dyspnea, fatigue, lymphedema and quality of life in breast cancer patients receiving chemo-radiotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aaliya Javed 
Designation  PG student 
Affiliation  SGT University 
Address  Faculty of Physiotherapy, SGT University, Gurgaon-Badli Road Chandu, Budhera, Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  8002607948  
Fax    
Email  aaliyajaved98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Reyalch 
Designation  Assistant Professor 
Affiliation  SGT University 
Address  Faculty of Physiotherapy SGT University, Gurgaon-Badli Road Chandu, Budhera, Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  8826043916  
Fax    
Email  neha_fphy@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Aaliya Javed 
Designation  PG student 
Affiliation  SGT University 
Address  Faculty of Physiotherapy SGT University, Gurgaon-Badli Road Chandu, Budhera, Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  8002607948  
Fax    
Email  aaliyajaved98@gmail.com  
 
Source of Monetary or Material Support  
Faculty of Physiotherapy, SGT University, Gurgaon-Badli Road Chandu, Budhera, Haryana-122505 
 
Primary Sponsor  
Name  Aaliya Javed 
Address  SGT University, Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aaliya Javed  Lymphocare  Building no.178’179, Main, Shaheed Major Vikas Yadav Marg, near reliance fresh, 122001
Gurgaon
HARYANA 
8002607948

aaliyajaved98@gmail.com 
Aaliya Javed  Max Hospital  Press Enclave Road, New Delhi, Delhi 110017
New Delhi
DELHI 
8002607948

aaliyajaved98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Faculty of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1- Expiratory Muscle Training with Conventional Chest physiotherapy with kinesio taping and relaxation exercises  PEP IMT sessions per day, consisting of 30 breaths against a resistance of 50% of their PImax for 7 day per week with Conventional chest physiotherapy, kinesio taping and relaxation exercises. 
Comparator Agent  Group 2- Inspiratory Muscle Training with Conventional Chest physiotherapy with kinesio taping and relaxation exercises  IMT (Inspiratory muscle training) sessions per day, consisting of 30 breaths against a resistance of 50% of their PImax for 7 day per week with Conventional Chest physiotherapy, kinesio taping and relaxation exercises 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1) Female breast cancer patients diagnosed with Stage I-III.
2) Stable patients with breast cancer who have completed the adjuvant treatment or were allowed to undergo the treatment.
3) Willingness to participate in cardio-oncology rehabilitation sessions.
4) Ability to comprehend and respond to questionnaires or assessments related to dyspnea, fatigue, lymphedema, and quality of life.
5) Ability to provide informed consent for participation in the study.
 
 
ExclusionCriteria 
Details  1) Presence of uncontrolled cardiac symptoms.
2) Patients with metastatic breast cancer or Stage IV disease.
3) History of significant cardiovascular diseases or conditions that contraindicate participation in cardio-oncology rehabilitation.
4) Severe psychiatric disorders that may impede participation in the study or comprehension of study procedures.
5) Pregnancy, as it may affect the interpretation of study outcomes and participation in rehabilitation exercises. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Modified Borg Scale
2) Respiratory muscle function 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) Arm circumference
2) EORTC QLQ-C30 questionnaire
3) NPRS
4) Brief Fatigue Inventory/Modified Brief Fatigue Inventory 
4 weeks 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   30/12/2024 
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="0"
Months="6"
Days="6" 
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  

Breast cancer is the most prevalent cancer among women worldwide and represents nearly a quarter of all malignant tumors in women, with over one million new cases diagnosed annually. It is a complex and heterogeneous disease characterized by diverse histological patterns, biological features, and clinical behaviors. While advancements in early detection and treatment have improved survival rates, persistent treatment-related symptoms, such as dyspnea, fatigue, and lymphedema, significantly impact the quality of life for survivors. These symptoms are often underdiagnosed and inadequately managed, particularly respiratory impairments linked to chemotherapy and radiotherapy, including pulmonary toxicity from agents like docetaxel. Inspiratory Muscle Training (IMT) and Positive Expiratory Pressure (PEP) IMT have shown promise in improving respiratory function and endurance, but their role in managing dyspnea and enhancing quality of life in breast cancer patients undergoing treatment remains underexplored. Addressing this gap, this study aims to evaluate the effectiveness of IMT and PEP IMT within a cardio-oncology rehabilitation framework. By examining their impact on dyspnea, fatigue, lymphedema, and overall quality of life, the research seeks to provide evidence-based insights to optimize care for breast cancer patients undergoing chemo-radiotherapy, advancing toward more holistic and effective treatment strategies.

Null Hypothesis H0 - There is no significant effect of PEP IMT than traditional methods in cardio-oncology rehabilitation on dyspnea, fatigue, lymphedema and quality of life in breast cancer patients receiving chemo-radiotherapy.

Alternate Hypothesis H1 - There is significant effect of PEP IMT than traditional methods in cardio-oncology rehabilitation on dyspnea, fatigue, lymphedema and quality of life in breast cancer patients receiving chemo-radiotherapy.

 
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