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

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.