Prevention of paclitaxel-related neurological side effects with lithium – a randomized, double-blind, placebo-controlled, explorative proof-of-concept phase II clinical trial to counteract chemotherapy induced neurotoxicity

Phase 2

Recruiting

• Conditions: C50.9; G62.0; Breast, unspecified; Drug-induced polyneuropathy

• Registration Number: DRKS00027165
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 93

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 (nab-) paclitaxel therapy
- Karnofsky index =70 %

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 for amphetamine, barbiturates, benzodiazepines, cocaine, methamphetamine, methadone, opiates, THC 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, 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 <70ml/min/1.73m2

Placebo:
- Documented 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
• Study Design: Not specified