ABCB1 SNPs as Predictors of PIPN

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05093023

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aim is to determine the allele frequencies of 1236 G>A and 3435 G>A in ABCB1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in Egyptian patients. Additionally, the study aimed at fitting and validating logistic regression models with the aforementioned SNPs evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.

Condition or Disease	Intervention/Treatment	Phase
Paclitaxel Adverse Reaction Neuropathy;Peripheral Breast Cancer	Genetic: Real-Time PCR

Study Design

Study Type:

Observational

Actual Enrollment :

92 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

ABCB1 Single Nucleotide Polymorphism Genotypes as Predictors of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 31, 2020

Outcome Measures

Primary Outcome Measures

Grade 2 or higher peripheral neuropathy [12 weeks]
Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Egyptian females ≥18 years of age.
Histologically confirmed Breast Cancer.
Receiving conventional neoadjuvant or adjuvant weekly paclitaxel.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (UNL), total bilirubin ≤1.5x UNL, absolute neutrophil count ≥1.5 x 10^{9/L, platelet count ≥100 x
10}9/L, AST and ALT ≤3.0x UNL, and alkaline phosphatase ≤3.0x UNL).
No major neurological disease or symptoms prior to the start of paclitaxel therapy.
neither subjective nor objective evidence of metastatic disease.

Exclusion Criteria:

Pregnancy.
Patients with recurrent or metastatic (local or distant) breast cancer.
Neuropathic at the time of recruitment.
History of neuropathy prior to recruitment.
Previously exposed to taxanes or any other microtubule Inhibitors, or regimens including platinates.
Patients currently receiving dose-dense biweekly taxane-containing regimens.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nasser's Institute Hospital	Cairo	Aghakhan	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

nabil mahmoud, Master's Student, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05093023

Other Study ID Numbers:

ABCB1 in Paclitaxel Neuropathy

First Posted:

Oct 26, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Oct 26, 2021