Chemotherapy-induced Peripheral NeuropathyPhase 2NCT05966441
Role of Curcumin in Paclitaxel Induced PN
A Phase 2 study testing Curcumin and Paclitaxel in people with Chemotherapy-induced Peripheral Neuropathy, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Curcumin and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 10 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Effect of Curcumin in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
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.
Read the 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.
- Being tested
- Curcumin, Paclitaxel
- Keywords
- Paclitaxel, Curcumin, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary 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
PaclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Curcumin; Drug: Paclitaxel |
| Control group | Placebo comparator | Patients will receive their Paclitaxel-based chemotherapy only Receives: Dietary Supplement: Curcumin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline
Secondary outcomes (1)
Evaluate the effect of adding curcumin to paclitaxel-based chemotherapy on response rate in neoadjuvant therapy.
CT scan will be done before first dose of paclitaxel and at the end of the course
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start30 Aug 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966441
- Sponsor's protocol ID
- Paclitaxel induced PN
- Status last verified
- Jul 2023
- First submitted
- 7 Apr 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 31776306Al 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.
PubMed 22648527Babu 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.
PubMed 25429779Saghatelyan 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.
PubMed 32335356
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Curcumin in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05966441
- Acronym / sponsor ID
- Paclitaxel induced PN
- Keywords
- Paclitaxel, Curcumin, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Curcumin, Drug: PaclitaxelPatients will receive their Paclitaxel-based chemotherapy along with Curcumin at a dose of oral 2g daily till the end of chemotherapy. |
| Control group | Placebo comparator | Dietary Supplement: Curcumin, Drug: PaclitaxelPatients will receive their Paclitaxel-based chemotherapy only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminThe 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 | Dietary supplement | Control group, Experimental group |
| PaclitaxelPaclitaxel (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. | Drug | Control group, Experimental group |
Primary outcome
Evaluate the effect of Curcumin on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.
Time frame: Baseline
After each cycle, initial evaluation of response will be done guided by clinical examination and functional assessment and questionnaire.
Evaluate the effect of Curcumin on the damage of nerve fibers induced by paclitaxel.
Time frame: Baseline
Nerve growth factor level will be obtained at day 0 and at the end of the paclitaxel course
1 secondary outcome
Evaluate the effect of adding curcumin to paclitaxel-based chemotherapy on response rate in neoadjuvant therapy.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 31776306Zhang 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.
- Background: PubMed 22648527Al 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.
- Background: PubMed 25429779Babu 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.
- Background: PubMed 32335356Saghatelyan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin and Paclitaxel in people with Chemotherapy-induced Peripheral Neuropathy, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif Gawish, master student (00201019700299, sherif.gawish2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of Curcumin on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966441, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.