| CTRI Number |
CTRI/2025/11/097399 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Phase 2 Placebo-controlled prospective RCT evaluation of efficacy and in patients undergoing treatment with platinum based agents and or taxanes
|
|
Scientific Title of Study
|
To evaluate the efficacy and safety of combining N-Palmitoylethanolamide (PEA), Agmatine sulfate, beta-caryophyllene, and carnosic acid(PACC) with Duloxetine (D) (PACC-D) compared to Duloxetine (D) alone in reducing chemotherapy-induced neuropathic pain in patients undergoing treatment with platinum-based agents and/or taxanes : A Phase-3,Double blinded, Placebo-controlled prospective RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Kapoor |
| Designation |
Professor, Department of Medical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Department of medical oncology,OPD room No.28 Ground floor DNT Block,Mahamana Pandit Madan Mohan Malviya Cancer center (MPMMCC)Sundarpur Varansi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
0
India |
| Phone |
9950482121 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHREYA SRIVASTAVA |
| Designation |
Senior Resident |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Department of medical oncology,
OPD room No.28 Ground floor DNT Block,Mahamana Pandit Madan Mohan Malviya Cancer center (MPMMCC)Sundarpur Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
Nill
India |
| Phone |
9235230804 |
| Fax |
|
| Email |
shreyampmmcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHREYA SRIVASTAVA |
| Designation |
Senior Resident |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Department of medical oncology,
OPD room No.28 Ground floor DNT Block,Mahamana Pandit Madan Mohan Malviya Cancer center (MPMMCC)Sundarpur Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
Nill
India |
| Phone |
9235230804 |
| Fax |
|
| Email |
shreyampmmcc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahamana Madan Mohan Malviya Cancer Center (MPMMCC) India 221005 |
|
|
Primary Sponsor
|
| Name |
Mahamana Madan Mohan Malviya Cancer Center (MPMMCC) |
| Address |
Mahamana Madan Mohan Malviya Cancer Center.BHU Campus,Naria Road.Sundar Bagiya Colony.Varansi,uttar pradesh-221005
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAkhil kapoor |
Mahamana Madan Mohan Malaviya Cancer Center Varansi(MPMMCC) |
OPD-28 Ground floor Mahamana Pandit Madan Mohan Malaviya Cancer Center,Sundar Bagiya ,Near Nariya road,BHU Campus, Varansi 221005,Uttar Pradesh
Varanasi
UTTAR PRADESH |
9950482121
kapoorakhil1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G652||Sequelae of toxic polyneuropathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PACC |
N-Palmitoylethanolamide (PEA), Agmatine sulfate, beta-
caryophyllene, and carnosic acid(PACC) Orally 1000mg BD for 3 month |
| Comparator Agent |
Placebo |
Sugar based compound , Duloxetine 20mg HS ( can be increased to 30 mg BD depending on tolerability) + Placebo 1 BD daily for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Eligible patients equal or greater than 18 years of age undergoing taxane/platin-based chemotherapy
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1)Prior or ongoing treatment with other neurotoxic chemotherapeutic agents will
not be allowed.
2) Participants with a documented medical history of
a) neuropathy from any type of nerve compression (e.g. carpal/tarsal tunnel
syndrome, radiculopathy, spinal stenosis, brachial plexopathy),
b) leptomeningeal carcinomatosis,
c) severe depression,
d) suicidal ideation,
e) bipolar disease,
f) alcohol abuse,
g) a major eating disorder, and
h) markedly abnormal renal or liver function tests will be ineligible. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in pain by BPI-SF on (DAY 1 WEEK 1 – DAY 1 WEEK 13) +/-10 days |
0 to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of pain on the functional status BPI SF (DAY 1 WEEK 1 – DAY 1 WEEK 13) +/-10 days |
0 to 12 weeks |
Difference in quality of life FACT GOG NTx (DAY 1 WEEK 1 – DAY 1 WEEK 13) +/-10 days between two arms of
study. |
0 to 12 weeks |
| Adverse effects |
0 to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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 2 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| 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 Applicable |
| 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
|
Protocol Title: " Phase 2 RCT for evaluating the efficacy and safety of combining NPalmitoylethanolamide (PEA), Agmatine sulfate, beta-caryophyllene, and carnosic acid(PACC) with Duloxetine (D) (PACC-D) compared to Duloxetine (D) alone in reducing chemotherapy-induced neuropathic pain in patients undergoing treatment with platinum-based agents and/or taxanes : A Phase 2 Placebo-controlled prospective RCT" Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect experienced by cancer patients undergoing treatment with neurotoxic chemotherapeutic agents, particularly platinum-based drugs and taxanes. It manifests as a range of sensory and motor symptoms, including tingling, numbness, pain, and weakness in the extremities, and significantly impacts patients’ quality of life and treatment outcomes, often persisting even after treatment completion. Till now breakthroughs for this debilitating condition have only been Duloxetine which has shown only some moderate effect. This is a phase 2 prospective study to evaluate whether addition of some organic extracts to duloxetine can lead to better responses. The study will be performed in all patients who develop chemotherapy induced peripheral neuropathy of grade 1 or more either on treatment or within 3 months of treatment with taxanes and/or platins. The patients will be screened clinically and randomly divided into 2 study groups. Each of the group shall receive the standard of care drug along with either placebo or the experimental drug. Responses will we assessed using the questionnaire handouts. Each group shall we assessed at 0, 6 and 12 weeks. Total duration of study will be 18 months (first patients first visit to last patients last visit). All the patients (in both groups) will bear the cost of standard of care drug. The cost of additional drug will be borne by study team/hospital. Each patient shall receive standard of care Duloxetine starting from 20mg per day to the maximum of 30mg BD (depending on tolerance). The supportive drug has to be taken twice a day daily for period of 3 months. Average follow-up of each patient will be around 3months.No major adverse effects have been reported with the experimental drugs. However, in exceptional situation if grade 3 or 4 toxicity do occur the treatment will be stopped immediately and hospital care will be proved. Assess the impact of adding the novel combination therapy (PACC) to standard care with duloxetine alone in improving chemotherapy-induced peripheral neuropathy (CIPN) and enhancing the quality of life for patients suffering from this debilitating side effect of chemotherapy. |