Clinical trial · Interventional
Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients
Evaluation of Lithium Efficacy Against Chemotherapy Induced Neutropenia in Breast Cancer Patients
NCT05221593CI-TRIAL-00061606completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Using Lithium Carbonate to decrease incidence of neutropenia caused by using chemotherapy regimen in breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lithium Carbonate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group
- description
- will receive chemotherapy regimen with placebo
- type
- EXPERIMENTAL
- label
- study group
- description
- 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.
- interventionNames
- Drug: Lithium Carbonate
Primary outcomes (1)
- measure
- change in white blood cells count
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1\. All patients presented with breast cancer documented by pathological reports stage I, II and III. 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.
References
Publications (18)
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- BACKGROUNDel-Mallakh RS. Lithium. Conn Med. 1990 Mar;54(3):115-26. PMID 2182284
- BACKGROUNDSlater V, Milanes F, Talcott V, Okafor KC. Influence of age on lithium therapy. South Med J. 1984 Feb;77(2):153-4, 158. doi: 10.1097/00007611-198402000-00003. PMID 6701582
- BACKGROUNDYassa R. Leukocytosis during long-term lithium treatment. N Y State J Med. 1981 Sep;81(10):1479-80. No abstract available. PMID 6792575
- BACKGROUNDBallin A, Lehman D, Sirota P, Litvinjuk U, Meytes D. Increased number of peripheral blood CD34+ cells in lithium-treated patients. Br J Haematol. 1998 Jan;100(1):219-21. doi: 10.1046/j.1365-2141.1998.00537.x. PMID 9450814
- BACKGROUNDRADOMSKI JL, FUYAT HN, NELSON AA, SMITH PK. The toxic effects, excretion and distribution of lithium chloride. J Pharmacol Exp Ther. 1950 Dec;100(4:1):429-44. No abstract available. PMID 14804282
- BACKGROUNDPetrini M, Vaglini F, Carulli G, Azzara A, Ambrogi F, Bertelli A. Effects of lithium and rubidium on the differentiation of mononuclear cells. Int J Tissue React. 1986;8(5):391-2. PMID 3781770
- BACKGROUNDTisman G, Herbert V, Rosenblatt S. Evidence that lithium induces human granulocyte proliferation: elevated serum vitamin B 12 binding capacity in vivo and granulocyte colony proliferation in vitro. Br J Haematol. 1973 Jun;24(6):767-71. doi: 10.1111/j.1365-2141.1973.tb01704.x. No abstract available.