| 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
|
|
|
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
|
|
|
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. |