Clinical trial NCT05966441: Role of Curcumin in Paclitaxel Induced PN
Official title: Evaluating the Effect of Curcumin in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Paclitaxel
Curcumin
Breast Cancer
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Details of the research steps that the subscriber will be exposed to:
* Base line evaluation then alignment in either intervention or control group either for taking the interventional drug or standard of care in control group.
* Blood samples will be collected at baseline.
* Patient will be given a weekly supply of the medication and will be asked to take his prescribed dose daily.
* Every week all patients will be asked about their symptoms and if they experience any adverse drug reaction.
* Patients will receive the interventional drug until the last paclitaxel dose will be taken.
* After 3 months, another full clinical examination and blood sample will be obtained.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The work is a prospective, randomized, open label controlled study. A total of 90 breast cancer female patients will be enrolled in the study. Eligible patients will simply be randomized using random allocation generator, after the end of anthracycline adjuvant therapy to one of two groups, Group I: will receive paclitaxel regimen plus 2g of curcumin Group II: will receive paclitaxel regimen only.

The cases involved in the study will be recruited from Ain Shams Teaching Hospital.

All patients presenting to the department were assessed for eligibility according to certain inclusion and exclusion criteria.

Details of the research steps that the subscriber will be exposed to:

* Base line evaluation then alignment in either intervention or control group either for taking the interventional drug or standard of care in control group.
* Blood samples will be collected at baseline.
* Patient will be given a weekly supply of the medication and will be asked to take his prescribed dose daily.
* Every week all patients will be asked about their symptoms and if they experience any adverse drug reaction.
* Patients will receive the interventional drug until the last paclitaxel dose will be taken.
* After 3 months, another full clinical examination and blood sample will be obtained.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the effect of Curcumin on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.
timeFrame: Baseline
measure: Evaluate the effect of Curcumin on the damage of nerve fibers induced by paclitaxel.
timeFrame: Baseline
Secondary outcomes:
measure: Evaluate the effect of adding curcumin to paclitaxel-based chemotherapy on response rate in neoadjuvant therapy.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang 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.
citation: Al 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.
citation: Babu 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.
citation: Saghatelyan 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 18;70:153218. doi: 10.1016/j.phymed.2020.153218. Online ahead of print.