Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients

Phase 3

Completed

• Conditions: Neutropenia
• Interventions: Drug: Lithium Carbonate

• Registration Number: NCT05221593
• Lead Sponsor: Al-Azhar University

Brief Summary

Using Lithium Carbonate to decrease incidence of neutropenia caused by using chemotherapy regimen in breast cancer patients.

Detailed Description

Introduction:
...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-12-25
• Study First Submitted QC: 2022-01-23
• Study First Posted: 2022-02-03
• Primary Completion: 2022-04-01
• Study Completion: 2022-06-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. All patients presented with breast cancer documented by pathological reports stage I, II and III.

Read More

Exclusion Criteria

1. Patients receiving cardiac medication such as diuretics.
2. Patients on sodium-restricted diet (to avoid lithium toxicity).
3. Stage IV with expected short overall survival.
4. Patients with blood or bone marrow cancer (to prevent interference).
5. Patients with hepatic and renal impairment.
6. Patient with untreated hypothyroidism.
7. Pregnant and breast feeding patients.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Lithium Carbonate	will receive chemotherapy regimen with Lithium Carbonate in controlled release formula (400mg b.i.d). In order to avoid the potential for bone marrow stimulation at the time chemotherapy was administered, the administration of lithium was started 24 hours after the administration of chemotherapy and continued for 18 days of every 21.the lithium serum level will be measured at specific times to ensure lithium serum level between 0.4-0.8 mmol\\L along the treatment course.

Primary Outcome Measures

Name	Time	Method
change in white blood cells count	At baseline (on the 1st day of first cycle) before chemotherapy administration and after each cycle (on the 18th day of every cycle) for six cycles of chemotherapy. (each cycle is 21 days)

Secondary Outcome Measures

Name	Time	Method
CXCL12	At baseline (on the 1st day of first cycle) before chemotherapy administration and after completion of six cycles of chemotherapy (on the 18th day of sixth cycle). (each cycle is 21 days)
CXCL1	At baseline (on the 1st day of first cycle) before chemotherapy administration and after completion of six cycles of chemotherapy (on the 18th day of sixth cycle). (each cycle is 21 days)
G-CSF	At baseline (on the 1st day of first cycle) before chemotherapy administration and after completion of six cycles of chemotherapy (on the 18th day of sixth cycle). (each cycle is 21 days)

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Non-US/Non-Canadian, Egypt