Stibium Metallicum Praeparatum D6 Versus Placebo in the Reduction of Paclitaxel-induced Peripheral Neurotoxicity

NCT04715542 | Not Yet Recruiting Phase 3

• 1 other identifier: 12012021
• Study Type: interventional
• Target: 86
• 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 trial, aiming to determine whether treatment with SMP reduces the severity of 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 FACT/GOG-NTX questionnaire (FACT/GOG-NTX: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, Score rage of NTX-subscale: 0-44, the higher the score, the better the QOL)

  Weekly from week 1 (Baseline) - 13

Secondary Outcomes (5)

• Occurrence and severity of paclitaxel-induced peripheral neuropathy over the whole study period

  12-week chemotherapy: Weekly from week 1-19 and week 24, 36, 48, 60; 18-week chemotherapy: Weekly from week 1-25, and week 30, 42, 54, 66

• Oncologist's evaluation CIPN

  12-week chemotherapy: Week 1, 4, 7, 10, 13, 19, 24, 36, 48, 60; 18-week chemotherapy: Week 1, 4, 7, 10, 13, 16, 19, 25, 30, 42, 54, 66

• Chemotherapy adherence

  12-week chemotherapy: Week 13; 18-week chemotherapy: Week 19

• Effect on Quality of life (QOL)

  12-week chemotherapy: Week 1, 7, 13, 19, 24, 36, 48, 60; 18-week chemotherapy: Week 1, 7, 13, 19, 25, 30, 42, 54, 60

• Biomarker for CIPN

  Week 1, 13, 19

Other Outcomes (3)

• Adherence to study medication (I)

  12-week chemotherapy: Weekly from week 1-19; 18-week chemotherapy: Weekly from week 1-25

• Adherence to study medication (II)

  12-week chemotherapy: Week 19; 18-week chemotherapy: Week 25

• Severe adverse events

  12-week chemotherapy: Week 1, 4, 7, 10, 13, 19, 24, 36, 48, 60; 18-week chemotherapy: Week 1, 4, 7, 10, 13, 16, 19, 25, 30, 42, 54, 66

Study Arms (2)

Stibium metallicum praeparatum D6

EXPERIMENTAL

Patients are treated with Stibium metallicum praeparatum D6 (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 D6 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 D6

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

You may qualify if:

• Age ≥ 18
• Early breast cancer, ovarian cancer or other gynecological cancer
• Patients who are about to receive a treatment with paclitaxel for 12 or 18 weeks (weekly or three-weekly) as part of adjuvant or neo-adjuvant chemotherapy.
• 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 depression or epilepsy
• Allergy to milk protein

Sponsors & Collaborators

• University of Bern: lead
• University Hospital, Basel, Switzerland: collaborator

Study Officials

• Ursula Wolf, Prof. Dr.

  University of Bern

  STUDY DIRECTOR

• Anton Oseledchyk, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Erni, PhD

CONTACT

+41316841563; silvia.erni@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 trial

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share