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A Phase 2 Placebo-controlled prospective RCT evaluation of efficacy and in patients undergoing treatment with platinum based agents and or taxanes

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 - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097399
Enrollment
132
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G652- Sequelae of toxic polyneuropathy

Interventions

Intervention1: (PACC-D) Vs (D): Evaluation of efficacy and safety of combining N-Palmitoylethanolamide (PEA), Agmatine sulfate, beta-caryophyllene, and carnosic acid (PACC) with Duloxetine (D) (PACC-D

Sponsors

Mahamana Madan Mohan Malviya Cancer Center (MPMMCC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eligible patients equal or greater than 18 years of age undergoing taxane/platin-based chemotherapy

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Difference in pain by BPI-SF on (DAY 1 WEEK 1 – DAY 1 WEEK 13) +/-10 daysTimepoint: 0 to 12 weeks—

Secondary

MeasureTime frame
Effect of pain on the functional status BPI SF (DAY 1 WEEK 1 – DAY 1 WEEK 13) +/-10 daysTimepoint: 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.Timepoint: 0 to 12 weeks;Adverse effectsTimepoint: 0 to 12 weeks—

Countries

India

Contacts

Public ContactDr SHREYA SRIVASTAVA

Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)

shreyampmmcc@gmail.com9235230804

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026