Role of Curcumin in Paclitaxel Induced PN

NCT05966441 | Unknown Phase 2 FDA Drug

• 1 other identifier: Paclitaxel induced PN
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Paclitaxel; Curcumin; Breast Cancer

Outcome Measures

Primary Outcomes (2)

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

  After each cycle, initial evaluation of response will be done guided by clinical examination and functional assessment and questionnaire.

  Baseline

• Evaluate the effect of Curcumin on the damage of nerve fibers induced by paclitaxel.

  Nerve growth factor level will be obtained at day 0 and at the end of the paclitaxel course

  Baseline

Secondary Outcomes (1)

• Evaluate the effect of adding curcumin to paclitaxel-based chemotherapy on response rate in neoadjuvant therapy.

  baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients will receive their Paclitaxel-based chemotherapy along with Curcumin at a dose of oral 2g daily till the end of chemotherapy.

Dietary Supplement: Curcumin; Drug: Paclitaxel

Control group

PLACEBO COMPARATOR

Patients will receive their Paclitaxel-based chemotherapy only

Dietary Supplement: Curcumin; Drug: Paclitaxel

Interventions

Curcumin DIETARY_SUPPLEMENT

The safety of curcumin has been widely demonstrated, and curcumin has a variety of potential pharmaceutical applications. Curcumin exhibits antioxidant, anti-inflammatory and anticancer properties and has been described as neuroprotective against neurological disorders. Many of curcumin's pharmacological benefits arise from its antioxidant or anti-inflammatory properties. Curcumin appears to have significant potential for treatment of diseases that result from oxidative stress. Curcumin is provided in soft gelatin capsules each capsule contains 1 g of curcumin and patient is asked to take 2 capsules daily

Control group; Experimental group

Paclitaxel DRUG

Paclitaxel (PTX), the most widely used anticancer drug, is applied for the treatment of various types of malignant diseases. Mechanisms of PTX action represent several ways in which PTX affects cellular processes resulting in programmed cell death. PTX is frequently used as the first-line treatment drug in breast cancer Paclitaxel dose in adjuvant therapy after doxorubicin and cyclophosphamide every 3 weeks 175mg/m2 IV or Weekly 80 mg/m2 IV.. Paclitaxel dose in neoadjuvant therapy every 3 weeks 175 mg/m2 IV.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (4)

• 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.

  PMID: 31776306 BACKGROUND

• 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.

  PMID: 22648527 BACKGROUND

• 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.

  PMID: 25429779 BACKGROUND

• 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 15;70:153218. doi: 10.1016/j.phymed.2020.153218. Epub 2020 Apr 18.

  PMID: 32335356 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Curcumin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Central Study Contacts

Sherif Gawish, master student

CONTACT

00201019700299; sherif.gawish2020@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: July 28, 2023
• Study Start: August 30, 2023
• Primary Completion: December 15, 2023
• Study Completion: March 10, 2024
• Last Updated: July 28, 2023

Record last verified: 2023-07