NCT03492047

Brief Summary

The purpose of the study is to evaluate the effect of N-acetyl cysteine in combination with paclitaxel on the clinical outcomes of patients with peripheral neuropathy, paclitaxel-induced peripheral neuropathy affect quality of life in cancer patients. new therapeutic approches such as the antioxidant N-acetyl cysteine, showed to has neuroprotective effect, the aim of the study is to evaluate the effect of N- acetylcysteine(NAC) administration in the prevention of paclitaxel-Induced peripheral neuropathy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

March 2, 2018

Last Update Submit

February 25, 2020

Conditions

Peripheral Neuropathy Due to Chemotherapy

Keywords

paclitaxelperipheral neuropathyN-acetyl cysteine

Outcome Measures

Primary Outcomes (1)

  • Incidence of chemotherapy induced-peripheral neuropathy

    Number of patients reported neuropathy from paclitaxel

    up to 12 week

Secondary Outcomes (3)

  • severity of chemotherapy induced-peripheral neuropathy

    at baseline and before each cycle up to 12 week

  • Adverse effects

    at baseline and each cycle up to 12 week

  • severity of chemotherapy induced-peripheral neuropathy

    at baseline, at the end of 6 cycle and at the end of 12 cycles

Other Outcomes (3)

  • the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale

    weekly up to 12 week

  • serum nerve growth factor

    at baseline and after 12 week

  • serum malionaldehyde

    at baseline and after 12 week

Study Arms (3)

control

ACTIVE COMPARATOR

they will receive paclitaxel 80 mg/m2 once per week for 12 weeks only

Drug: Paclitaxel

high dose N-acetyl cysteine

EXPERIMENTAL

they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and high dose N-acetylcysteine (1200 mg twice daily) for the paclitaxel treatment period

Dietary Supplement: high dose N-acetylcysteineDrug: Paclitaxel

low dose N-acetyl cysteine

EXPERIMENTAL

they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and low dose N-acetylcysteine (600mg twice daily) for the paclitaxel treatment period.

Dietary Supplement: low dose N-acetylcysteineDrug: Paclitaxel

Interventions

low dose N-acetylcysteineDIETARY_SUPPLEMENT

N-acetylcysteine 600mg twice daily

low dose N-acetyl cysteine
high dose N-acetylcysteineDIETARY_SUPPLEMENT

N-acetylcysteine 1200mg twice daily

high dose N-acetyl cysteine
PaclitaxelDRUG

Paclitaxel 80mg /m2 IV

controlhigh dose N-acetyl cysteinelow dose N-acetyl cysteine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\>18 years old).
  • Breast cancer patients who will receive adjuvant weekly paclitaxel for 12 cycles.
  • ECOG performance status 0-2
  • Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine \<1.5 mg/dl).

You may not qualify if:

  • Patients who have any of the following:
  • Clinical neuropathy.
  • Diabetes mellitus.
  • Patients receiving vitamin B1, B6, B12,or other vitamin supplemental therapy.
  • Patients receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
  • Hypersensitivity to NAC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams University Hospitals

Cairo, 11566, Egypt

Location

Related Publications (1)

  • Khalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29.

    PMID: 32601973DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

AcetylcysteinePaclitaxel

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Hadeer G Khalefa, master

    Nassar institute for research and treatment hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pharmacist

Study Record Dates

First Submitted

March 2, 2018

First Posted

April 10, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

June 30, 2019

Last Updated

February 27, 2020

Record last verified: 2020-02

Locations

EG(1)