Clinical trial · Interventional

Role of Curcumin in Paclitaxel Induced PN

Evaluating the Effect of Curcumin in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients

NCT05966441CI-TRIAL-00068340unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Paclitaxel induced peripheral neuropathy is the most common and serious side effect associated with Paclitaxel treatment in breast cancer patients receiving Paclitaxel. The efficacy of antioxidant molecules as neuroprotective strategies to preventing the development of peripheral neuropathy has been investigated in preclinical and clinical studies. Vitamin E and Glutathione have been explored as adjuvant therapies to preventing taxane-induced peripheral neuropathy. Other tested neuroprotective treatments with limited success include amifostine, glutamine and acetyl l-carnitine. Curcumin's antioxidant capacity is similar to other potent antioxidants, such as trolox (a vitamin E analog). Curcumin inhibits lipid peroxidation in different tissues, regulates intracellular levels of antioxidant enzymes (e.g., catalase, glutathione peroxidase and superoxide dismutase) and is an effective intracellular reactive oxygen species (ROS) scavenger. The investigators are going to investigate the neuroprotective effect of Curcumin against Paclitaxel induced peripheral neuropathy.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chemotherapy-induced Peripheral Neuropathy	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Curcumin	Dietary Supplement	—	UNRESOLVED
Paclitaxel	Drug	Paclitaxel	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Experimental group
description
Patients will receive their Paclitaxel-based chemotherapy along with Curcumin at a dose of oral 2g daily till the end of chemotherapy.
interventionNames
1. Dietary Supplement: Curcumin
2. Drug: Paclitaxel
type
PLACEBO_COMPARATOR
label
Control group
description
Patients will receive their Paclitaxel-based chemotherapy only
interventionNames
1. Dietary Supplement: Curcumin
2. Drug: Paclitaxel

Primary outcomes (2)

measure
Evaluate the effect of Curcumin on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

Inclusion Criteria:

* Clinical diagnosis of early stage breast cancer with age \> 18 years.
* Performance status of the patients based on Eastern Cooperative Oncology Group (ECOG) from 0 to 2.
* Patients must receive paclitaxel 80 mg/m2 weekly or 175 mg/m2 every 3 weeks for 12 weeks.
* Patients clinical parameters should be (ANC ≥ 1500/mm3). Platelet count 100,000/mm3) (serum total bilirubin \< 1.5 mg/dl) and (creatinine \< 1.5 mg/dl).

Exclusion Criteria:

* Patients they had any signs and symptoms of clinical neuropathy.
* Diabetes mellitus
* Patients receiving vitamin supplementation including vitamin B1, B6 and B12
* Patients receiving antidepressants, anticoagulants, opioids or anticonvulsants
* Patients had a hypersensitivity to curcumin.

References

Publications (4)

BACKGROUNDZhang X, Guan Z, Wang X, Sun D, Wang D, Li Y, Pei B, Ye M, Xu J, Yue X. Curcumin Alleviates Oxaliplatin-Induced Peripheral Neuropathic Pain through Inhibiting Oxidative Stress-Mediated Activation of NF-kappaB and Mitigating Inflammation. Biol Pharm Bull. 2020 Feb 1;43(2):348-355. doi: 10.1248/bpb.b19-00862. Epub 2019 Nov 26. PMID 31776306
BACKGROUNDAl Moundhri MS, Al-Salam S, Al Mahrouqee A, Beegam S, Ali BH. The effect of curcumin on oxaliplatin and cisplatin neurotoxicity in rats: some behavioral, biochemical, and histopathological studies. J Med Toxicol. 2013 Mar;9(1):25-33. doi: 10.1007/s13181-012-0239-x. PMID 22648527
BACKGROUNDBabu A, Prasanth KG, Balaji B. Effect of curcumin in mice model of vincristine-induced neuropathy. Pharm Biol. 2015 Jun;53(6):838-48. doi: 10.3109/13880209.2014.943247. Epub 2014 Nov 28. PMID 25429779
BACKGROUNDSaghatelyan T, Tananyan A, Janoyan N, Tadevosyan A, Petrosyan H, Hovhannisyan A, Hayrapetyan L, Arustamyan M, Arnhold J, Rotmann AR, Hovhannisyan A, Panossian A. Efficacy and safety of curcumin in combination with paclitaxel in patients with advanced, metastatic breast cancer: A comparative, randomized, double-blind, placebo-controlled clinical trial. Phytomedicine. 2020 Apr 15;70:153218. doi: 10.1016/j.phymed.2020.153218. Epub 2020 Apr 18. PMID 32335356