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CTRI Number  CTRI/2024/10/075636 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 21/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the prevention of pain syndrome caused by chemotherapy paclitaxel in cancer patients by oral drug duloxetine compared to placebo. 
Scientific Title of Study   Randomized, double-blind, placebo-controlled study of oral duloxetine in the prevention of acute pain syndrome in patients receiving paclitaxel 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Atul Batra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Room 160 D, 1st floor, IRCH, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9013078407  
Fax    
Email  batraatul85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Atul Batra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Room 160 D, 1st floor, IRCH, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9013078407  
Fax    
Email  batraatul85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Atul Batra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Room 160 D, 1st floor, IRCH, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9013078407  
Fax    
Email  batraatul85@gmail.com  
 
Source of Monetary or Material Support  
All India institue of Medical Sciences, Ansari nagar,New Delhi, India Pincode:110029 
 
Primary Sponsor  
Name  Indian Council of Medical Resaerch 
Address  Indian Council of Medical Research, Ansari Nagar, New Delhi India Pincode:110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Batra  All India Institute of Medical Sciences  160D, 1st Floor, B.R Ambedkar Institutes Rotary Cancer Institute, All India Institute of Medical Sciences, Ansari Nagar
South
DELHI 		 9013078407

batraatul@gmail.com 
Dr Prabhat Bhargava  Tata Memorial Centre  Dr. E Borges Road, Parel, Mumbai -400 012
Mumbai
MAHARASHTRA 		 7276174221

bhargava611@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics commitee, Tata Memorial Centre Mumbai  Approved 
Institutes ethics committe, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Duloxetine  Duloxetine 30 mg, oral administration, once daily for 7 days following the paclitaxel infusion in a patient with breast cancer 
Comparator Agent  Placebo  Matched placebo 30 mg, oral administration, once daily following the paclitaxel infusion in a patient with breast cancer 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Commencing paclitaxel at a planned dose of 175 mg/m2 as single-agent chemotherapy
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
3. Study treatment is both planned and able to start within 14 days of randomization
4. Willing and able to comply with all study requirements, including treatment (taking duloxetine orally), timing and/or nature of required assessments
 
 
ExclusionCriteria 
Details  1. The patients with pre-existing chronic pain or peripheral neuropathy
2. History of hypersensitivity to paclitaxel
3. Pregnant or lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Incidence of acute pain syndrome after paclitaxel administration  At the end of Cycle 1 of paclitaxel (day 14 or end of week 2)
 
 
Secondary Outcome  
Outcome  TimePoints 
The proportion of patients who develop peripheral neuropathy across the two arms.
 		 At baseline, 3rd, 5th, 7th, & 9th week. 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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 
Date of First Enrollment (India)   01/11/2024 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   The study starts enrolling patients with any stage of breast cancer who will be scheduled to start with paclitaxel treatment. After screening and registration, enrollment starts if the patient fulfills the inclusion and exclusion criteria. Duloxetine will be administered following paclitaxel infusion for 7 days and four cycles. Endpoints assessment as per the protocol and recruitment will last for 6-9 months. 
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