| CTRI Number |
CTRI/2025/12/098731 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [exercise ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of aerobic and resistance exercise training on the inflammatory markers in patients with breast cancer undergoing chemotherapy |
|
Scientific Title of Study
|
Effect of exercise training on the inflammatory profile in patients with breast cancer undergoing chemotherapy: an open label randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rose Babu |
| Designation |
Associate Professor and PhD student |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Physiology,
Jubilee Mission Medical College and Research Institute, East fort, Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9972820843 |
| Fax |
|
| Email |
rosebabu515@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biju Bahuleyan |
| Designation |
Professor, HOD and guide |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Physiology,
Jubilee Mission Medical College and Research Institute, East fort, Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9846915151 |
| Fax |
|
| Email |
drbijubahuleyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biju Bahuleyan |
| Designation |
Professor, HOD and guide |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of Physiology,
Jubilee Mission Medical College and Research Institute, East fort, Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9846915151 |
| Fax |
|
| Email |
drbijubahuleyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee Mission Medical College and Research Institute, East fort, Thrissur, Kerala, India - 680005 |
|
|
Primary Sponsor
|
| Name |
Dr Rose Babu |
| Address |
Department of Physiology,
Jubilee Mission Medical College and Research Institute, East fort, Thrissur, Kerala, India - 680005 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rose Babu |
Jubilee Mission Medical College and Research Institute |
Department of Medical Oncology,Diamond block,East fort, Thrissur - 680005
Thrissur
KERALA |
9972820843
rosebabu515@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
Patients with breast cancer on chemotherapy and who will not be undergoing any intervention. In this arm, no exercise intervention is given to the patients . The routine treatment care such as chemotherapy and other hospital care will be provided. |
| Intervention |
Exercise |
Aerobic exercise - home based walking exercise for 3 days per week
Resistance training exercise - 2 days per week
Stretching and breathing exercise for the rest of the days
Aerobic and resistance exercises will be given after 2 days of each chemotherapy cycle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Female patients who are diagnosed with breast cancer (Stage 1 to stage 3) and about
to undergo neoadjuvant or adjuvant chemotherapy (cyclophosphamide-anthracycline
regimen).
Normal cardiovascular, hepatic and renal function.
Patients who are willing to participate. |
|
| ExclusionCriteria |
| Details |
Patients with Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
Currently with any musculoskeletal disturbances, severe respiratory illness, autoimmune diseases.
Patients who are pregnant.
Who had undergone major surgeries within past 3 months
Known case of any psychiatric disorders, intellectual disabilities.
Under regular moderate to high intensity exercise (after calculation of physical
activity level (PAL).
Receiving chronic anti-inflammatory medications for other diseases. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inflammatory marker |
3 time points. Baseline - before chemotherapy, 6 weeks- after mid and 12 weeks - at the end of chemotherapy cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body composition, Muscle strength, Quality of life |
Baseline, 6 weeks after mid & 12 weeks at the end of chemotherapy cycles |
| Chemotherapy toxicity, Relative dose intensity |
3 weeks, 6 weeks, 9 weeks & 12 weeks after every cycle of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/02/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is an open label single centered randomized controlled trial to determine the effect of exercise training on the inflammatory profile of patients with breast cancer undergoing chemotherapy -anthracycline and cyclophosphamide regimen, when compared to patients who are on treatment without any exercise intervention. A total of 60 patients will be recruited for the study and randomized into intervention and control groups.The primary outcome will be inflammatory markers like TNF-a, CRP which will be investigated at the baseline -before chemotherapy, at the middle of chemotherapy treatment cycles and at the end of chemotherapy cycles. The secondary outcome will be body composition, muscle strength, quality of life, investigated at the baseline, at the middle of chemotherapy treatment cycles and at the end of chemotherapy cycles and other outcomes like treatment toxicity and relative dose intensity will be investigated after each cycle of chemotherapy. |