Stibium Metallicum Praeparatum 6x Versus Placebo in the Prevention of Paclitaxel-induced Peripheral Neurotoxicity

NCT04715542 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 12012021
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. The proposed trial is a parallel, double blind, placebo controlled, randomised, phase III superiority trial, aiming to determine whether treatment with SMP prevents incidence of or reduces the severity symptoms of paclitaxel-induced peripheral neuropathy, as compared to placebo.

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Outcome Measures

Primary Outcomes (1)

• Reduction in neuropathy severity

  Measured by the neurotoxicity subscale (NTX-subscale) of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX)

  Week 18

Secondary Outcomes (7)

• Reduction of occurrence (incidence) of paclitaxel- or nab-paclitaxel-induced peripheral neuropathy

  Baseline, Week 3, Week 6, Week 9, Week 12, Week 18; Follow up: Weeks 24, 36, 48, 60

• Benefit of study medication on Quality of life

  Baseline, Week 3, Week 6, Week 9, Week 12, Week 18; Follow up: Weeks 24, 36, 48, 60

• Benefit of study medication on pain

  Baseline, Week 3, Week 6, Week 9, Week 12, Week 18; Follow up: Weeks 24, 36, 48, 60

• Benefit of study medication on depression

  Baseline, Week 12, Follow up: Weeks 24, 36, 48, 60

• Benefit of study medication on anxiety

  Baseline, Week 12, Follow up: Weeks 24, 36, 48, 60

Other Outcomes (2)

• Adherence to study medication

  Baseline, Week 3, Week 6, Week 9, Week 12, Week 18

• Severe adverse events

  Baseline, Week 3, Week 6, Week 9, Week 12

Study Arms (2)

Stibium metallicum praeparatum 6x

EXPERIMENTAL

Patients are treated with Stibium metallicum praeparatum 6x (subcutaneus injection), which is authorized in Switzerland and is listed by Swissmedic as an authorized anthroposophic medicinal product.

Drug: Stibium metallicum praeparatum 6x

Saline subcutaneous injection

PLACEBO COMPARATOR

Placebo (a saline subcutaneous injection) is chosen as comparator to the treatment group.

Drug: Placebo

Interventions

Stibium metallicum praeparatum 6x DRUG

Stibium metallicum praeparatum 6x will be administered with subcutaneous injections 3 times a week at 1 ampoule at 1 mL during the chemotherapy and shall be continued during 6 weeks after the end of chemotherapy . The first injection will be administered on the day of the first dose of chemotherapy, before the injection of the first dose of chemotherapy.

Stibium metallicum praeparatum 6x

Placebo DRUG

Placebo will be administered with subcutaneous injections 3 times a week at 1 ampoule at 1 mL during the chemotherapy and shall be continued during 6 weeks after the end of chemotherapy . The first injection will be administered on the day of the first dose of chemotherapy, before the injection of the first dose of chemotherapy.

Saline subcutaneous injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Individuals with early breast cancer, stage I to IIIC, who are about to receive a paclitaxel-based neo-adjuvant or adjuvant chemotherapy, with a planned dosing regimen of 80 mg of paclitaxel per square meter of body surface by intravenous infusion weekly for 12 doses.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Ability to provide informed consent as documented by signature
• Ability to read, write, and speak German

You may not qualify if:

• Patients with pre-existing neuropathy
• Prior chemotherapy with taxanes or other neurotoxic agents
• 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.
• 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
• Life expectancy \< 3 months

Sponsors & Collaborators

• University of Bern: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• Hospital of Thun: collaborator
• Tumor- und BrustZentrum Ostschweiz: collaborator
• Gesundheitszentrum Fricktal AG: collaborator
• Kantonsspital Winterthur KSW: collaborator
• Kantonsspital Graubünden: collaborator
• Kantonsspital Aarau: collaborator

Study Officials

• Ursula Wolf, Prof. Dr.

  University of Bern

  STUDY DIRECTOR

• Manuela Rabaglio, Dr. med.

  University of Bern

  PRINCIPAL INVESTIGATOR

• Christoph Ackermann, Dr. med.

  Hospital Thun

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliane Timm, PhD

CONTACT

+41316848145; eliane.timm@unibe.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized-controlled, double-blind, multicentric superiority trial

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share