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

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.

Sex

Female

Minimum age

18 Years

Inclusion criteria

* 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

Exclusion Criteria:

* 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