| 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
|
|
|
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
|
|
|
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 |