Role of Curcumin in Paclitaxel Induced PN

Ain Shams University

Status and phase: Not yet enrolling; Phase 2

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Dietary Supplement: Curcumin; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT05966441

Paclitaxel induced PN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups, including a placebo group

Experimental group

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.

Treatment:

Drug: Paclitaxel

Dietary Supplement: Curcumin

Control group

Placebo Comparator group

Description:

Patients will receive their Paclitaxel-based chemotherapy only

Treatment:

Drug: Paclitaxel

Dietary Supplement: Curcumin