FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074440 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Extracorporeal Shockwave Therapy versus Complex Decongestive Therapy in Breast Cancer Related Lymphedema 
Scientific Title of Study   Effectiveness of Extracorporeal Shockwave Therapy versus Complex Decongestive Therapy in Breast Cancer Related Lymphedema: A Single Blinded Randomized 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  Asmita Shrestha 
Designation  Post Graduate Student 
Affiliation  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD No 39, Room No 29, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  08217820534  
Fax    
Email  asmitashresthapt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nikita Pawar 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD No 39, Room No 29, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9731012979  
Fax    
Email  nikitapawar@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Nikita Pawar 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD No 39, Room No 29, Nehru Nagar, Belagavi, Karnataka


KARNATAKA
590010
India 
Phone  9731012979  
Fax    
Email  nikitapawar@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research, Nehru Nagar, Belagavi, Karnataka, India, 590010 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD No 39, Room No 29, Nehru Nagar, Belagavi, Karnataka, India, 590010 
Type of Sponsor  Private medical college 
 
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 Nikita Pawar  KLEs Dr. Prabhakar Kore Hospital  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD No 39, Room No 29, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA 		 9731021979

nikitapawar@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D059||Unspecified type of carcinoma in situ of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Complex Decongestive Therapy  Complex Decongestive Therapy will include Manual Lymphatic drainage, Remedial exercises and Intermittent Pneumatic Compression Therapy. It will be given 3 times a week for 3 weeks 
Intervention  Extracorporeal Shockwave Therapy and Remedial Exercises  Extracorporeal Shockwave Therapy and Remedial exercises will be given three times a week for three weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Female 
Details  1. All referred cases of breast cancer patients with lymphedema, aged 18 years and above
2. Lymphedema secondary to breast cancer treatment
3. Unilateral lymphedema 
 
ExclusionCriteria 
Details  1. Metastatic cancer
2. Active leukemia
3. Acute inflammation and infection
4. Severe trauma or disruptive surgery to arm
5. Pregnancy/Breast feeding
6. Previously undergone Complex Decongestive Therapy or any form of physical therapy within 3 months 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Arm circumference using measuring tape. Shoulder pain and disability using Shoulder pain and Disability Index  Pre- Baseline
Post- after 1, 2 and 3 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Hand grip strength using Dynamometer, Quality of life by using Functional Assessment of Cancer Therapy Breast (FACT-B) and Neuropathic symptoms by using Functional Assessment of Cancer Therapy/Gynaecologic Oncology-Neurotoxicity (FACT-GOG NTx)  Pre- Baseline
Post- after 1, 2 and 3 weeks 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/10/2024 
Date of Study Completion (India) 24/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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   Effectiveness of Extracorporeal Shockwave Therapy Versus Complex Decongestive Therapy in Breast Cancer-Related Lymphedema: A Single-Blinded Randomized Controlled Trial

Aim of Study: To compare the effectiveness of Extracorporeal Shockwave Therapy Versus Complex Decongestive Therapy for Breast Cancer-Related Lymphedema

Null Hypothesis: There will be no significant difference between the effect of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in terms of arm circumference, shoulder pain and disability, hand grip strength, quality of life and neuropathic symptoms in particpants with breast cancer related lymphedema. 

Alternate hypothesis: There will be significant difference between the effect of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in terms of arm circumference, shoulder pain and disability, hand grip strength, quality of life and neuropathic symptoms in particpants with breast cancer related lymphedema.

Inclusion Criteria: 1. All referred cases of Breast cancer patients with lymphedema, aged 18 years and above 2. Lymphedema secondary to breast cancer treatment 3. Unilateral lymphedema

Exclusion criteria: 1. Metastatic cancer 2. Active leukemia 3. Acute inflammation and infection 4. Severe trauma or disruptive surgery to arm 5. Pregnancy, Breast feeding 6. Previously undergone CDT or any form of physical therapy within 3 months

A written informed consent will be obtained from the participants. A brief demographic data will be obtained from the subjects prior to assessment. Baseline assessment of the particpants will be done before the intervention. Then the particpants will be divided into two groups i.e. Extracorporeal Shockwave Therapy group (n=11) and Complex Decongestive Therapy group (n=11). Both groups will be treated 3 times a week for 3 weeks and data will be collected and analysed.

 
Close