Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients

NCT05221593 | Completed Phase 3

• 1 other identifier: lithium and breast cancer
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

Study Arms (2)

control group

NO INTERVENTION

will receive chemotherapy regimen with placebo

study group

EXPERIMENTAL

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.

Drug: Lithium Carbonate

Interventions

Lithium Carbonate DRUG

400 mg tablet in controlled released formula

Also known as: Prianil controlled-release tablet

study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, Non-US/Non-Canadian, 11765, Egypt

Location

Related Publications (18)

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MeSH Terms

Conditions

Neutropenia

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: February 3, 2022
• Study Start: August 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

EG (1)