Stibium Metallicum Praeparatum Versus Placebo in the Prevention of Paclitaxel- or Nab-paclitaxel-induced Peripheral Neuropathy: the StibTax RCT

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Chemotherapy induced peripheral neuropathy (CIPN) is one of the most limiting side effects of chemotherapy and often leads to adaptations in the protocol of the chemotherapy including dose reduction or even discontinuation of treatment. In general, the symptoms of CIPN are sensory, often distributed in a "stocking and glove" manner, and include pain, tingling, and numbness. CIPN has a marked negative influence on quality of life of patients and their families. It may result in serious limitations in daily functioning and affect the enjoyment, social relationships, and ability to perform work. Current management of CIPN (i.e. prevention and treatment) includes dose reduction or delay of chemotherapy cycles and treatment discontinuation. Unfortunately, this reduces the chance of an effective cancer treatment. Current guidelines of the American Society of Clinical Oncology (ASCO) on the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy do not conclusively recommend any agent for the prevention of CIPN. Due to the scarcity of drugs that are effective for preventing and treating CIPN, the distress of patients who suffer from CIPN, and the major societal and economic costs, new approaches and effective treatment strategies are required.

An observational study which started in January 2017 in the outpatient clinic of the Institute of Complementary and Integrative Medicine at the University of Bern showed promising results regarding the medical treatment of CIPN with Stibium metallicum praeparatum 6x. Patients received Stibium metallicum praeparatum 6x for prevention or treatment of chemotherapy-induced peripheral sensory neuropathy, respectively. The study included 91 patients, and patients indeed showed lower incidence rates of (20%, 2 months after they started with Stibium), as compared to the incidence of 57-83% reported by the NCCN task force.

Building on this observational study, the current study investigates the efficacy and tolerance of Stibium metallicum praeparatum 6x (Weleda) to prevent paclitaxel- or nab-paclitaxel-induced peripheral neuropathy as reported by patients. As secondary outcomes, the influence on quality of life and chemotherapy treatment adherence of patients is assessed. As the clinical experience with Stibium metallicum praeparatum 6x suggests promising results for CIPN prevention, a double blind, bicentric, randomized controlled trial will be conducted to address the efficacy of Stibium metallicum praeparatum 6x with a sound scientific approach. Stibium metallicum praeparatum 6x has been used in adults and children for several decades and has demonstrated no harm. Consequently, no adverse events are expected.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bern
• Collaborators: Hospital of Thun; University Hospital Inselspital, Berne

Criteria

Inclusion Criteria:

• Age ≥ 18

• Cancer patients who are about to receive paclitaxel- or nab-paclitaxel-based adjuvant, neoadjuvant, or palliative chemotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2

• Ability to provide informed consent as documented by signature

• Ability to read, write, and speak German

Exclusion Criteria:

• Patients with pre-existing neuropathy

• Prior chemotherapy with taxanes or other neurotoxic agents

• Diabetes mellitus

• Gastric cancer

• Inpatients

• Concomitant medications that are known to cause neuropathy

• Pregnancy or lactation

• Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.

• Significant uncontrolled cardiac disease (e.g. unstable angina)

• Patients with psychiatric, addictive or any disorder that prevents the patient from adhering to the protocol requirements, in the opinion of the investigator

• Lactose intolerance or glucose-galactose-malabsorption, as well as any other contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product

• Participation in another study with investigational drug within 30 days preceding and during the present study

• Life expectancy < 3 months