| CTRI Number |
CTRI/2025/03/083738 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of a structured exercise programme in improving outcome in terms of shoulder function after breast cancer surgery |
|
Scientific Title of Study
|
Effect of STructured
Exercise
Program in improving functional morbidity and quality of life in Breast Cancer patients undergoing curative-intent surgery: A Randomized Controlled Trial (STEP-BC) |
| Trial Acronym |
STEP-BC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avisikta Mallick |
| Designation |
Academic Senior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Surgical Oncology, OPD room 510
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8017999074 |
| Fax |
|
| Email |
dravisiktamallick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeewar Ram Vishnoi |
| Designation |
Additional Professor and Head |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Surgical Oncology
Academic building, Room no-3152
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8017999074 |
| Fax |
|
| Email |
drjvishnoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avisikta Mallick |
| Designation |
Academic Senior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Surgical Oncology
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8017999074 |
| Fax |
|
| Email |
dravisiktamallick@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS,Jodhpur |
| Avisikta Mallick
Academic SR
Dept. of Surgical Oncology
AIIMS, Jodhpur.
Dist-Jodhpur
Rajasthan
India.
PIN-342005 |
|
|
Primary Sponsor
|
| Name |
Dr Avisikta Mallick |
| Address |
Department of Surgical Oncology, AIIMS, Jodhpur
District-Jodhpur, State-Rajasthan,
India.
PIN-342005 |
| 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 Avisikta Mallick |
AIIMS, Jodhpur |
Phase II, Basni Industrial Area
Department of Surgical Oncology
OPD Room number 510
Jodhpur
RAJASTHAN |
8017999074
dravisiktamallick@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 |
| Intervention |
Structured Exercise Programme |
Pre operative work out.
Immediate Post operative-walking
b. relaxation
c. Diaphragmatic breathing
d. Ball squeezing
e. Stretching
And then gradual increase in shoulder and arm exercises over 1 month to do
Arm raising up to 180 degree, wall pushing, side bending, shoulder blade stretch and squeeze, elbow winging, wand exercise, stretching using resistance band |
| Comparator Agent |
Usual physiotherapy |
Deep breathing exercises 6times daily.
Shoulder and upper limb active and passive ROM exercises like raising arm above shoulder, combing, eating-3 to 4 times daily.
Opening and closing fist with arm kept raised- 15-20 times daily.
Elbow flexion to touch the same sided and opposite sided shoulder. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Eastern Clinical Oncology Group- Performance score (ECOG-PS): 0-2
2. Biopsy proven- non metastatic breast carcinoma
3. Undergoing surgery with curative intent. |
|
| ExclusionCriteria |
| Details |
1.Second primary/ recurrent cancer.
2. Patients with severe comorbidities, distant metastasis
3.Patients already having shoulder disability due to preexisting shoulder joint
pathology
4. Patient’s current physical or mental condition not allowing to undergo a vigorous exercise programme
5. Patients not willing to participaTe |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess whether the structured exercise program (SEP) improves the
functional morbidity in the form of DASH (Disability of Arm, Hand, and Shoulder) score at 3
and 6 months among breast cancer patients undergoing curative-intent surgery. |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare short- and long-term morbidity (wound related, pain, fatigue, lymphedema,
etc. between two groups
2. To compare the change in long-term functional outcomes using the DASH score at 12
months
3. To compare the Health-Related Quality of Life outcomes measures (FACT B+4 &
FACT-F score) between two groups.
4. To evaluate the effect of a structured exercise program in metabolic syndrome in
the form of improvement in Metabolic Syndrome (MetS) z score at 6 months |
6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="1"
Months="6"
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
|
The study has been proposed with an aim to study the impact of structured exercise programme in comparison to usual care on postoperative functional outcomes in patients with breast cancer undergoing curative intent surgery. This has been supported with the background of improved post operative functional outcome in terms of improved DASH score, Quality of life in terms of FACT B+4 score and improved metabolic syndrome score (MetS z score) and improved fatigue score (FACT-F score). All women undergoing breast cancer surgery in our institute will be included in the study. Women already having some shoulder dysfunction or with metastatic breast carcinoma will be excluded from the study.One structured exercise programme will be developed which will be validated among the current study population and it can be delivered by the treating surgeon himself/herself to all the breast cancer survivors for their long term functional recovery. |