| CTRI Number |
CTRI/2024/03/064164 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of L-carnitine in treating myopathy and peripheral neuropathy caused by paclitaxel in breast cancer patients. |
|
Scientific Title of Study
|
Effectiveness of L-carnitine on paclitaxel induced myopathy and peripheral neuropathy in breast cancer patients : A randomized, double blind, placebo-controlled trail. |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Duraimavalavan |
| Designation |
Assistant professor |
| Affiliation |
SRM Medical College Hospital and Research centre, |
| Address |
4th floor,Room no C-4/23 ,Division:Department of medical oncology,SRM Medical College Hospital and Research centre, Mahatma Gandhi Rd Potheri SRM Nagar Kattankulathur Tamil Nadu
Kancheepuram
TAMIL NADU
603211
India |
| Phone |
9941702373 |
| Fax |
|
| Email |
dmavalavan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T M Vijayakumar |
| Designation |
Professor & Head of the Department, Pharmacy practice |
| Affiliation |
SRM COLLEGE OF PHARMACY, SRMIST |
| Address |
4th floor,Room no:J-4/02 ,Divison:Department of pharmacypractice,SRM Medical College Hospital and Research centre, Mahatma Gandhi Rd Potheri SRM Nagar Kattankulathur Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
Vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T M Vijayakumar |
| Designation |
Professor & Head of the Department, Pharmacy practice |
| Affiliation |
SRM COLLEGE OF PHARMACY, SRMIST |
| Address |
4th floor,Room no:J-4/02 ,Divison:Department of pharmacypractice,SRM Medical College Hospital and Research centre, Mahatma Gandhi Rd Potheri SRM Nagar Kattankulathur Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
Vijaypractice@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRM college of pharmacy SRMIST |
|
|
Primary Sponsor
|
| Name |
SRM College of Pharmacy |
| Address |
SRM college of pharmacy
Intra college Rd,Potheri,SRM Nagar,Kattankulathur, Tamilnadu 603203 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| JEGANATHAN D |
SRM Medical college hospital & research centre |
4th floor,Room no C-4/23 ,Department of medical oncology,SRM Nagar Potheri Chengalpattu.
Kancheepuram
TAMIL NADU |
9894302212
djeganathan04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical College Hospital and research centre SRM nagar, Potheri, Kattankulathur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paclitaxel + placebo |
Dose - 500mg
Frequency- thrice daily for 6 months
|
| Intervention |
Paclitaxel+L-carnitine |
Dose - 500mg
Frequency- thrice daily for 6 months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.patients with pre-existing myopathy and peripheral neuropathy induced by paclitaxel and those have high risk for developing these are included.
2.patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1.patients with history of ESRD and are excluded.
2.patients with peripheral neuropathy and myopathy precipitated by other disease and drugs are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum Creatine kinase MM (CK MM) and
Nerve conduction study |
Baseline and week 26 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="0"
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
|
It was evident that the patient receiving Paclitaxel as a first-line chemo therapeuticagent tend to develop myopathy on successive chemo-cycle. This myopathic condition expedite the reduction of quality of life of the patient receiving paclitaxel. The patient experience severe muscle fatigue and loss of strength which affects the daily activityof the patient and increase risk of fall by several folds. L-carnitine which is an energy sparing over the counter supplement works by producing energy (ATP) from the reserved fat in the body. The so-called ATP aids in providing energy and reduce the muscle fatigue. Ubiquitin proteasome system plays a role in protein breakdown in tissues. L-carnitine act on this system and prevents protein breakdown thereby prevent muscle loss and myopathy. L-Carnitine even improves the peripheral neuropathy by decreasing the numbness and pricking pain. Hence, we have designed an interventional trial to evaluate the effect of L-carnitine on paclitaxel induced myopathy and peripheral neuropathy in breast cancer patients |