Prevention of paclitaxel-related neurological side effects with lithium to counteract chemotherapy induced neurotoxicity

Phase 1

• Conditions: Breast cancer patients scheduled for treatment with paclitaxel chemotherapy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004172-30-DE
• Lead Sponsor: Charité – Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-16
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 84

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

- 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 investigator, or otherwise dependent on the sponsor, the investigator or study physicians.
- The patient previously received neurotoxic chemotherapy (especially: taxanes, platinum compounds, vinca alcaloids, proteasome inhibitors)
- The patient has a history of preexisting 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 is positive
- The patient has a cardiac pacemaker or other non-MRI suitable implants

Lithium carbonate:
- The patient has a known allergy against Lithium carbonate or other components of the IMP
- The patient has hereditary galactose intolerance, lactose insufficiency or glucose-galactose-malabsorption
- The patient has Brugada-Syndrom or Myasthenia gravis
- The patient’s family history is positive for lethal sudden cardiac arrest
- The patient uses phenytoin, fosphenytoin, carbamazepine, methyldopa, tricyclic antidepressants
- The patient has a diagnosis of severe cardiac arrhythmia
- The patient has a diagnosis of epilepsy, M. Addison, psoriasis
- The patient has chronic renal disease with a GFR <70ml/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
- The patient has a diagnosis of severe liver failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified