| CTRI Number |
CTRI/2024/08/072768 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of metformin with watchful observation in the treatment of breast lump |
|
Scientific Title of Study
|
Efficacy and Safety of Metformin compared to Watchful observation in Breast fibroadenoma- A randomized, controlled, assessor-blinded study from India |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keshav Kumar |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Pharmacology,
3rd floor,
College building,
Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
8757037157 |
| Fax |
|
| Email |
drkeshav912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh Mishra |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Pharmacology,
3rd floor,
College building,
Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
misrahitesh75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keshav Kumar |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Pharmacology,
3rd floor,
College building,
Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
8757037157 |
| Fax |
|
| Email |
drkeshav912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India,
PIN-800014 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Pharmacology,
Indira Gandhi Institute of Medical Sciences,
Patna
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indira Gandhi Institute of Medical Sciences |
Department of General Surgery |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prem Prakash |
Indira Gandhi Institute of Medical Sciences, Patna |
OPD, Department of General Surgery
Patna
BIHAR |
9801276237
drpremprakash01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N602||Fibroadenosis of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin |
1000 mg SR, BD, Oral for 24 weeks |
| Comparator Agent |
Watchful observation |
For 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosed cases of breast fibroadenoma with lump size less than4cm.
2. Not willing to undergo surgical interventions.
3. Pre-menopausal women aged 18 to 50 years old with one or more, unilateral or bilateral fibroadenoma.
4. Willing to participate and give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Lump size greater or equal than 4cm.
2. Pregnancy and breastfeeding.
3. Vegetarianism.
4. Body mass index (BMI) more than 29.9.
5. History of breast cancer.
6. Allergy to biguanides.
7. Present diabetes mellitus.
8. Metabolic syndrome.
9. Renal dysfunction and hepatic dysfunction.
10. Use of concomitant medications like oral contraceptives or any medicine containing estrogens or progestins or phytoestrogen containing medications, GnRH agonists and antagonists, clomiphene, tamoxifen, aromatase inhibitors, danazol, oral contraceptives or any medicine containing estrogens or progestins.
11. Irregular use of the medication or complete non-compliance.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage of patients with complete absence of any detectable mass (Regression rate).
2. Change in average size (both increment or decrement) and average number of lesions from baseline. |
At 12 and 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intolerability warranting dose reduction or drug withdrawal and any serious adverse effect.
2.Change in blood sugar level and HbA1c level from base line in pre-diabetics at each visit.
3. Change in BMI from baseline in overweight patients (BMI: 25-29.9) at each visit.
|
At weeks 1, 4, 8, 12, and 24. |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkeshav912@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 28-02-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Ø This study is a randomized, assessor-blinded, parallel group single-centre trial assessing efficacy and safety of metformin 1000 mg SR twice daily compared with Watchful observation for 24 weeks. The primary objective is to assess change in number and size of breast lumps while the secondary objective is to assess safety/tolerability in patients, effect of metformin on glycemic status in pre-diabetics, and effect of metformin on weight in overweight patients of breast fibroadenoma receiving metformin. The primary outcome measures will be proportion of patients with complete absence of any detectable mass (regression rate) and change in average size (both increment or decrement) and average number of lumps from baseline to be assessed at week 12 and 24. Secondary outcome measures will be intolerability warranting dose reduction or drug withdrawal and any serious adverse effect; change in blood sugar level and HbA1c level from baseline in pre-diabetics; and change in body mass index from baseline in overweight patients (BMI: 25-29.9) at weeks 1, 4, 8, 12 and 24.
|