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CTRI Number  CTRI/2026/03/106376 [Registered on: 17/03/2026] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Non-invasive external medical device for post-mastectomy rehabilitation.]  
Study Design  Single Arm Study 
Public Title of Study   Effect of using an external breast prosthesis on quality of life in women after breast removal surgery 
Scientific Title of Study   Impact of External Breast Prosthesis on Post-Mastectomy Quality of Life: A Single-Institution Study from a Tertiary Care Centre in Southern India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sravya Deepika Ganti 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Mangalagiri 
Address  Room no. 414, 4th floor, Department of Surgical Oncology, OPD Block, AIIMS Mangalagiri, Guntur

Guntur
ANDHRA PRADESH
522503
India 
Phone  08500098771  
Fax    
Email  deepika972@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sravya Deepika Ganti 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Mangalagiri 
Address  Room no. 414, 4th floor, Department of Surgical Oncology, OPD Block, AIIMS Mangalagiri, Guntur

Guntur
ANDHRA PRADESH
522503
India 
Phone  08500098771  
Fax    
Email  deepika972@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sravya Deepika Ganti 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Mangalagiri 
Address  Room no. 414, 4th floor, Department of Surgical Oncology, OPD Block, AIIMS Mangalagiri, Guntur

Guntur
ANDHRA PRADESH
522503
India 
Phone  08500098771  
Fax    
Email  deepika972@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh, India PIN CODE: 522503 
 
Primary Sponsor  
Name  Ganti Sravya Deepika 
Address  Assistant professor, Department of Surgical oncology, Room no. 414, 4th floor, OPD Block, AIIMS Mangalagiri, Guntur, 522503, Andhra Pradesh, India 
Type of Sponsor  Other [Principal Investigator] 
 
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 
Sravya Deepika Ganti  All India Institute of Medical Sciences, Mangalagiri  Room no. 414, 4th floor, OPD Block, AIIMS Mangalagiri, Guntur
Guntur
ANDHRA PRADESH 
08500098771

deepika972@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, AIIMS MANGALAGIRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External Breast Prosthesis  High quality silicon based External Breast Prosthesis at least for 6 months 
Comparator Agent  Single arm study (before the usage of external breast prosthesis)  Single arm study (before the usage of external breast prosthesis) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Women eighteen years or above who have undergone mastectomy unilateral or bilateral and have completed a minimum of three months postoperative period
No prior breast reconstruction or implant-based reconstruction
No current use of an external breast prosthesis
Willing to use an External Breast Prosthesis provided by the study and participate in followups
 
 
ExclusionCriteria 
Details  Active cancer recurrence or metastasis
Presence of severe comorbidities affecting Quality of Life measurement
Patients who refuse to use a prosthesis even when offered
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate changes in quality of life before and after using an external breast prosthesis.   Baseline, at 3 months after giving prosthesis and 6 months after giving prosthesis. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the factors influencing adherence to external breast prosthesis use.  3 months & 6 months after giving prosthesis 
2.To identify any challenges faced by patients in using prostheses.  3 months & 6 months after giving prosthesis 
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
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)   16/04/2026 
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="1"
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  

Breast cancer is the most common malignancy among women in India with mastectomy often being the primary treatment While breast reconstruction is an option many Indian women opt for external breast prostheses EBP due to financial constraints lack of awareness and limited access to reconstruction services However studies indicate that a significant proportion of post mastectomy patients rely on makeshift alternatives impacting their quality of life QoL

This prospective observational study aims to evaluate the impact of EBP on post mastectomy QoL using the BREAST Q questionnaire at AIIMS Mangalagiri The study will assess changes in QoL scores before and after EBP use along with factors influencing adherence and barriers to access The study duration is for one year The calculated sample size is 53 Post mastectomy women aged 18 years and above and at least three months post operation with no prior reconstruction will be included Patients will complete BREAST Q before EBP use then at three months and six months after application Eligible patients will be counselled on EBP benefits fitted with prostheses and followed up through outpatient visits or telephonic assessments BREAST Q scores will be analysed to determine improvements in psychosocial and physical well being Statistical analysis will be done using paired t tests or Wilcoxon signed rank test for pre and post intervention comparisons and repeated measures ANOVA for longitudinal QoL assessment at baseline three months and six months Expected outcomes include improved QoL self esteem and body image after EBP use and identification of key barriers to EBP adoption

This study will provide critical evidence to integrate post mastectomy rehabilitation into routine oncology care


 
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