Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715542
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-01-14
Brief Title:
Stibium Metallicum Praeparatum 6x Versus Placebo in the Prevention of Paclitaxel-induced Peripheral Neurotoxicity
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Subcutaneous Stibium Metallicum Praeparatum 6x Versus Placebo in the PRevention Of PaclitaxEL-induced Peripheral NeurOTOXicity the PROPEL NO TOX Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPEL NO TOX
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 ie 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
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
Detailed Description:
Chemotherapy-induced peripheral neuropathy CIPN is one of the most limiting side effects of chemotherapy and often leads to adaptations in the administration of the chemotherapy including dose reduction or even discontinuation of treatment In general the symptoms of CIPN are sensory often occuring in a stocking and glove manner and most commonly including tingling numbness and dysaesthesia In addition patients treated with agents inducing CIPN such as taxanes or platinum compounds also may experience motor symptoms which often present as distal or general weakness and autonomic nervous system dysfunction eg constipation or diarrhea abnormalities of sweating and lightheadedness andor dizziness with positional changes Furthermore patients with chronic symptoms report having unsteady gait putting them at higher risk of falling CIPN has a largest impact on quality of life and is associated with the development of psychological distress Cancer survivors report long-term peripheral neuropathy symptoms with impact on symptom burden functional status and quality of life Because of the growing prevalence of cancer and of cancer survivors the lack of adequate treatment or preventive strategies against CIPN as well as the major societal and economic costs CIPN is becoming a major issue
According to the National Comprehensive Cancer Network NCCN task force report the overall incidence of CIPN ranges from 57 up to 83 of patients treated with paclitaxel The incidence and prevalence of CIPN vary among neurotoxic agents dosing regimens intensity and cumulative dosing regimen selection eg combination taxanes and platinum compounds as well as in presence of preexisting neuropathy comorbidities and genetic susceptibility The analysis of the Japanese Adverse Drug Event Report database showed that more than 50 of CIPN associated with taxanes and platinum compounds occurred within four weeks
After completion of chemotherapy the prevalence of CIPN for neurotoxic chemotherapy overall one month after finishing chemotherapy is 68 dropping to 60 at 3 months and 30 at 6 months or more Severe symptoms are likely to persist longer In patients treated with taxanes nearly half of patients have symptoms 6 to 9 months after completing chemotherapy and many require years to recover if they recover at all In early-stage breast cancer patients treated with paclitaxel persistent numbness one year after treatment with paclitaxel were reported in approximately 67 to 80 of early-stage breast cancer patients Two years after the end of therapy 344 of breast cancer patients treated with paclitaxel reported neuropathy symptoms with 180 reporting more severe symptoms Another study showed that two or more years after diagnosis 44 of breast cancer survivors treated with paclitaxel reported long-term neuropathy symptoms
Current standard of care Current management of CIPN ie prevention and treatment includes dose reduction delay of chemotherapy cycles or treatment discontinuation This reduces the chance of an effective cancer treatment
The 2014 2020 and 2021 American Society of Clinical Oncology ASCO Guidelines on the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy did not recommend any agent for the prevention of CIPN and have cautiously recommended treatment of existing CIPN with duloxetine Preliminary evidence suggests a potential benefit from non-pharmacological treatments in the prevention andor treatment of chronic neuropathy including exercise acupuncture cryotherapy compression therapy and scrambler therapy Larger sample-sized definitive studies are needed to confirm efficacy and clarify risks of these interventions
Risk factors for CIPN Cumulative dose is a strong risk factor for the development of CIPN Other risk factors include dose per cycle treatment schedule number of injections duration of infusion prior or concomitant chemotherapy with neurotoxic agents ie vinca alkaloids taxanes platinum compounds epothilones including ixabepilone bortezomib thalidomide arsenice trioxides development and severity of acute neuropathy syndrome or acute pain syndrome within 1 to 4 days following the neurotoxic agent infusion comorbid health conditions associated with an increased risk of neuropathy ie diabetes mellitus excess alcohol HIV smoking decreased creatinine clearance folatevitamin B12 deficiency pre-existing peripheral neuropathy older age and higher body mass index Other clinical risk factors such as sedentary behavior insomnia fatigue anxiety and depression have been shown to increase CIPN prevalence Genetic factors may also be associated with risk of developing CIPN
Research question 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 This study investigates the efficacy and tolerance of Stibium metallicum praeparatum 6x Weleda also known as Antimon to prevent paclitaxel-induced peripheral neuropathy as reported by patients As secondary outcomes the influence on quality of life pain anxiety depression patients distress sleep disorder falls as well as on chemotherapy treatment adherence and dose of chemotherapy delivered is assessed
According to the National Comprehensive Cancer Network NCCN task force report the overall incidence of CIPN ranges from 57 up to 83 of patients treated with paclitaxel The incidence and prevalence of CIPN vary among neurotoxic agents dosing regimens intensity and cumulative dosing regimen selection eg combination taxanes and platinum compounds as well as in presence of preexisting neuropathy comorbidities and genetic susceptibility The analysis of the Japanese Adverse Drug Event Report database showed that more than 50 of CIPN associated with taxanes and platinum compounds occurred within four weeks
After completion of chemotherapy the prevalence of CIPN for neurotoxic chemotherapy overall one month after finishing chemotherapy is 68 dropping to 60 at 3 months and 30 at 6 months or more Severe symptoms are likely to persist longer In patients treated with taxanes nearly half of patients have symptoms 6 to 9 months after completing chemotherapy and many require years to recover if they recover at all In early-stage breast cancer patients treated with paclitaxel persistent numbness one year after treatment with paclitaxel were reported in approximately 67 to 80 of early-stage breast cancer patients Two years after the end of therapy 344 of breast cancer patients treated with paclitaxel reported neuropathy symptoms with 180 reporting more severe symptoms Another study showed that two or more years after diagnosis 44 of breast cancer survivors treated with paclitaxel reported long-term neuropathy symptoms
Current standard of care Current management of CIPN ie prevention and treatment includes dose reduction delay of chemotherapy cycles or treatment discontinuation This reduces the chance of an effective cancer treatment
The 2014 2020 and 2021 American Society of Clinical Oncology ASCO Guidelines on the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy did not recommend any agent for the prevention of CIPN and have cautiously recommended treatment of existing CIPN with duloxetine Preliminary evidence suggests a potential benefit from non-pharmacological treatments in the prevention andor treatment of chronic neuropathy including exercise acupuncture cryotherapy compression therapy and scrambler therapy Larger sample-sized definitive studies are needed to confirm efficacy and clarify risks of these interventions
Risk factors for CIPN Cumulative dose is a strong risk factor for the development of CIPN Other risk factors include dose per cycle treatment schedule number of injections duration of infusion prior or concomitant chemotherapy with neurotoxic agents ie vinca alkaloids taxanes platinum compounds epothilones including ixabepilone bortezomib thalidomide arsenice trioxides development and severity of acute neuropathy syndrome or acute pain syndrome within 1 to 4 days following the neurotoxic agent infusion comorbid health conditions associated with an increased risk of neuropathy ie diabetes mellitus excess alcohol HIV smoking decreased creatinine clearance folatevitamin B12 deficiency pre-existing peripheral neuropathy older age and higher body mass index Other clinical risk factors such as sedentary behavior insomnia fatigue anxiety and depression have been shown to increase CIPN prevalence Genetic factors may also be associated with risk of developing CIPN
Research question 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 This study investigates the efficacy and tolerance of Stibium metallicum praeparatum 6x Weleda also known as Antimon to prevent paclitaxel-induced peripheral neuropathy as reported by patients As secondary outcomes the influence on quality of life pain anxiety depression patients distress sleep disorder falls as well as on chemotherapy treatment adherence and dose of chemotherapy delivered is assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None