Breast cancer patients scheduled for treatment with paclitaxel chemotherapy
Conditions
Interventions
Product Name: Quilonum® retard
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LITHIUM CARBONATE
CAS Number: 554-13-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent is present - The patient has the capacity to give consent (she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention.) - Age 18-70 years - Recent diagnosis of breast cancer to be treated with weekly or biweekly paclitaxel therapy - Karnofsky index =70 % Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: -The patient is pregnant or breastfeeding -The patient with childbearing potential is not willing to use an acceptable form of contraception. -The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons. -The patient did or does participate in other interventional trials (6 months before and at the time of this trial) -The patient is legally detained in an official institution -The patient is an employee of the investigator study site, or a family member of the employees or the investigators, or otherwise dependent on the sponsor, the investigators or study physicians. -The patient previously received neurotoxic chemotherapy (especially: taxanes, platinum compounds, vinca alcaloids, proteasome inhibitors) -The patient has a history of pre-existing neuropathy with a baseline TNSr > 5 -The patient has a history of current or former alcohol or drug abuse or Carbohydrate Deficient Transferrin (CDT) > 2.4 % or urine drug screening for amphetamine, barbiturates, benzodiazepines, cocaine, methamphetamine, methadone, opiates, tetrahydrocannabinol is positive unless the positive result can be explained by prescribed medications -The patient has a cardiac pacemaker or other non-MRI suitable implants -Diagnosis of Covid-19 illness Lithium carbonate: -The patient has a known allergy against Lithium carbonate or other components of the IMP -The patient has one of the following confirmed diagnoses: hereditary galactose intolerance, lactase insufficiency or glucose-galactose-malabsorption -The patient has one of the following diagnoses: Brugada-Syndrome, Myasthenia gravis, M. Addison, myeloid leukemia, psoriasis, epilepsy, severe cardiac arrhythmia, severe hyponatremia, severe dehydration, severe hypothyreoidism, acute myocardial infarction, acute kidney failure -The patient’s family history is positive for confirmed lethal sudden cardiac arrest -The patient uses phenytoin, fosphenytoin, carbamazepine, methyldopa, tricyclic antidepressants -The patient has chronic renal disease with a GFR <60ml/min/1.73m2 Placebo: -Allergy to cellulose or lactose Paclitaxel: -The patient has a known allergy against paclitaxel or other components of the standard-medication (SMP) -The patient has a diagnosis of severe liver failure, based on routine standard care bloodwork
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this proof-of-concept exploratory clinical trial is to test the hypothesis that a co-medication with lithium carbonate (Quilonum® retard) is able to reduce the burden of chemotherapy induced neuropathy (CIN) as measured by the “Total Neuropathy Score reduced” (TNSr) in breast cancer patients undergoing neurotoxic chemotherapy with weekly (q1w) or biweekly (q2w) paclitaxel infusions.;Secondary Objective: To examine whether: Co-medication with lithium carbonate - results in a reduced number of patients with moderate to severe CIN - leads to less intake or lower doses of atypical pain medication - leads to fewer and less severe self-reported symptoms of CIN - improves the patients' quality of life - can reduce cognitive impairment caused by paclitaxel - can reduce the decrease in hippocampal volume and changes in structural connectivity - leads to lower concentrations of neurofilament light chain in serum Patients with co-medication of lithium carbonate tolerate higher cumulative doses of paclitaxel;Primary end point(s): Value of the “Total Neuropathy Score reduced” (TNSr) at 2 weeks after last paclitaxel chemotherapy. The score has a range of 0 to 28 points.;Timepoint(s) of evaluation of this end point: 2 weeks after last paclitaxel chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Indicator of mild vs. moderate vs. severe CIN as assessed by the TNSr at 2 weeks after last paclitaxel infusion: mild 1-10 points, 11-19 points moderate, 20-28 points severe. • Amount and dose of pain medication for CIN at 2 weeks after last paclitaxel infusion. • Number and cumulative dose of completed paclitaxel chemotherapy cycles at 2 weeks after last paclitaxel infusion. • Patient-reported severity of CIN assessed with the European Organisation for Research and Treatment of Cancer (EORTC) CIPN20 questionnaire at 2 weeks after the last paclitaxel infusion. The score has a range of 20 to 80 points. • Patient-reported quality of life assessed with the EORTC-QLQ-C30 quality of life questionnaire at 2 weeks after the last paclitaxel infusion. The score has a range from 30 to 126 points. • Patient-reported symptoms of anxiety and depression assessed with the Patient Health Questionnaire for Anxiety and Depression (PHQ-4) at 2 weeks after last paclitaxel infusion. The score has a range from 0 to 12 points. • Severity of cognitive impairment, tested with the CANTAB system (Cambridge Neuropsychological Test Automated Battery) at 2 respectively 6 weeks after the last paclitaxel infusion (V16 q1w and q2w). • Hippocampal volume and changes in structural connectivity measured by brain MRI at 2 respectively 6 weeks after the last paclitaxel infusion (V16 q1w and q2w). • Axonal damage assessed by serum neurofilament light chain (NFL) at 2 weeks after the last paclitaxel infusion.;Timepoint(s) of evaluation of this end point: 2 weeks after last paclitaxel infusion | — |
Countries
Germany
Contacts
Public ContactDepartment of Neurology / NCRC
Charité – Universitätsmedizin Berlin
Outcome results
None listed