Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2023-08-30
2024-03-10
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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.
PREVENTION
NONE
Study Groups
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Experimental group
Patients will receive their Paclitaxel-based chemotherapy along with Curcumin at a dose of oral 2g daily till the end of chemotherapy.
Curcumin
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
Paclitaxel
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
Patients will receive their Paclitaxel-based chemotherapy only
Curcumin
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
Paclitaxel
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.
Interventions
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Curcumin
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
Paclitaxel
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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Paclitaxel induced PN
Identifier Type: -
Identifier Source: org_study_id