Chemotherapy-induced Peripheral NeuropathyPhase 1/2NCT05052398
Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM, on Chemotherapy-induced Peripheral Neuropathy
A Phase 1/2 study testing PSP NEURO SERUM in people with Chemotherapy-induced Peripheral Neuropathy, run by Algenis SpA at 9 sites in Brazil.
Trial summary
Proof-of-concept study to assess the effects of gonyautoxins (PSP NEURO SERUM) on safety and tactile sensitivity on patients with chemotherapy-induced peripheral neuropathy (CIPN). This is a multicenter, prospective proof-of-concept study in patients with solid tumors affected by CIPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- PSP NEURO SERUM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 9 sitesBrazil
- Study dates
- 14 Jan 2021to 14 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥18 years
- Histological diagnosis of cancer (hematologic or solid tumors).
- Part 1: Treatment with antineoplastic agents that induce peripheral neuropathy in neoadjuvant, adjuvant, or metastatic scenario; Part 2: Treatment with taxanes peripheral neuropathy inducers in the neoadjuvant, adjuvant, or metastatic scenario.
- Peripheral sensory neuropathy grade 2 or higher on upper limbs as per NCI-CTCAE v5.0. and with alteration of the Semmes Weinstein monofilament test.
- Part 1: Diagnosis of peripheral sensory neuropathy during treatment with antineoplastic agents drugs that induce peripheral neuropathy or up to 2 weeks after the last chemotherapy infusion; Part 2: Diagnosis of peripheral sensory neuropathy during treatment with peripheral neuropathy-inducing taxanes or up to 2 weeks after last chemotherapy infusion.
Show all 11Show fewer
- Part 1: Patients with chronic symptoms related to peripheral sensory neuropathy who have completed treatment with peripheral neuropathy-inducing antineoplastic agents for more than 2 weeks and without any exclusion criteria, may be included. Part 2: Patients with chronic symptoms related to sensory peripheral neuropathy who completed treatment with peripheral neuropathy-inducing taxanes for more than 2 weeks and no exclusion criteria, can be included.
- Patients using neuropathic pain modulators will be allowed if there is no dose adjustments in the last 2 weeks and if sensory symptoms persist related to CIPN, or if the use is for another indication.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
- Documented willingness to use an effective contraceptive method while participate in the study for male patients with partners or female participants with the potential to become pregnant.
- Part 1: Hand skin and cuticles must be intact. Part 2: Skin of hands, feet and cuticles must be intact.
Who cannot join
- Prior treatment with gonyautoxins or any small molecule neurotoxins.
- Female participants who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or intend to become pregnant within 3 months.
- History of peripheral sensory neuropathy attributed to any cause other than chemotherapy.
- Patients receiving systemic treatment that has among its common side effects (> 1%) peripheral neuropathy, or who have received the same within the last 2 weeks. The use during the study of systemic drugs such as hormone therapy (e.g. tamoxifen, aromatase inhibitor, etc), or other agents that do not have among their common side effects (>1%) peripheral neuropathy, will be allowed.
- Patients with grade 2 CIPN with perceived improvement of symptoms.
- Changes in neuropathic pain modulators will not be allowed.
Show all 25Show fewer
- Any other therapies for chemotherapy-induced peripheral neuropathy must be discontinued at least 2 weeks before the first dose of study drug.
- Known hypersensitivity reaction to PSP Neuro serum.
- Patients with a known or suspected shellfish allergy.
- No dermatologic lesions on hands and feet and cuticles that might increase systemic exposure of the investigational medicinal product (IMP).
- Distal muscle weakness and/or atrophy.
- History of alcoholism or alcohol intake of 168g (21 units) for men and 112g (14 units) for women per week on a regular basis (time > 3 months). 1 unit = 10mL = 8g of pure alcohol.
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- Diagnosis of type I or II diabetes mellitus (regardless of management) that have symptoms attributable to diabetic neuropathy pre-treatment with chemotherapy. Well-controlled diabetic patients (regardless of management), previously asymptomatic may be included.
- Glycosylated hemoglobin (HbA1C) ≥8.0% at screening.
- Fasting serum glucose ≥ 160 mg/dL at screening. Fasting is defined as no caloric intake for at least 8 hours.
- Vitamin B12 deficiency defined as < 250 ng/mL.
- Phosphate levels above upper limit of normal (ULN).
- ECG: QTc interval (Fridericia Formula) ≥ 450ms.
- Positive Tinel and/or Phalen test.
- Participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry / randomization.
- Surgery, radiotherapy, or systemic therapy that in the investigators' opinion might interfere/ worsen symptoms and the evaluation of peripheral neuropathy within 2 weeks prior to trial entry /randomization.
- Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications.
- Unresolved clinically significant toxicity from prior therapy except for alopecia.
- Failure to adhere to study treatment and follow-up procedures.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites, 9 recruiting
- Recruiting
Oncoclinicas do Brasil Servicios Medicos SA
Belo Horizonte, Minas Gerais, 30.360-680
Thayara Christi Soares, +553198266045, thayara.soares@oncoclinicas.com
Rodrigo Guimaraes, MD
- Recruiting
Oncoclínicas Florianópolis
Florianópolis, Santa Catarina, 88015-020
Victor Hugo Fonseca De Jesus, victor.jesus@medicos.oncoclinicas.com
Victor Hugo Fonseca De Jesus, MD
- Recruiting
Oncoclínicas João Pessoa
João Pessoa, Paraíba, 58030-080
Jose Antonio Da Silva, +558182017010, jose.antonio@oncoclinicas.com
Juliana Goes Martins, MD
- Recruiting
Multihemo
Recife, Pernambuco, 50070-460
Jose Antonio Da Silva, +558182017010, jose.antonio@oncoclinicas.com
Marcelo Salgado, MD
- Recruiting
Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905
Thaiza Martins Medeiros Lombardo, +5521971380225, thaiza.lombardo@oncoclinicas.com
Fabiane Do Nascimento Ferreira, +5521971380225, fabiane.ferreira@oncoclinicas.com
- Recruiting
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40.170-110
Juliana da Silva Cardoso, +557183140522, juliana.dcardoso@oncoclinicas.com
Luciana Landeiro, MD
- Recruiting
Centro de Paulista de Oncologia
São Paulo, 04538-132
Mayara Batista Pinto, +5511971445373, mayara.pinto@oncoclinicas.com
Andrea Moraes, MD
- Recruiting
Centro Oncológico do Triângulo S.A.
Uberlândia, Minas Gerais, 38408-150
Tayanne Ferraz Da Silva Poberschnigg, +553498323218, tayanne.poberschnigg@oncoclinicas.com
Florença Copati, MD
- Recruiting
Oncoclínicas Vitória
Vitória, Espírito Santo, 29050-400
Gabrielle Modenesi Venancio, 27992362044, gabrielle.venancio@oncoclinicas.com
Roberto de Oliveira Lima, MD
About this study
Official title: Proof of Principle Study Evaluating the Effects of Gonyautoxins, Paralytic Shellfish Poisoning (PSP) NEURO SERUM, on Objective and Subjective Symptoms of Chemotherapy-induced Peripheral Neuropathy (CINP)
Proof-of-concept study to assess the effects of gonyautoxins (PSP NEURO SERUM) on safety and tactile sensitivity on patients with chemotherapy-induced peripheral neuropathy (CIPN). This is a multicenter, prospective proof-of-concept study in patients with solid tumors affected by CIPN. The study will be divided into two parts: Part 1 will assess the activity and tolerability of PSP NEURO SERUM and part 2 consists of a randomized cohort that will compare the activity of PSP NEURO SERUM vs placebo. Part 2 will depend on the results of part 1. If there are less than 8 responses in part 1, the study will be interrupted, and it will not be recommended to proceed with part 2.
Read the detailed description
A multicenter, prospective proof-of-concept study in patients with solid tumors who developed chemotherapy-induced peripheral neuropathy (CIPN) in upper limbs, equal or greater than grade 2, according to NCI-CTCAE version 5.0. Patients must have been treated with cytotoxic agents known to cause CIPN in neoadjuvant, adjuvant or palliative setting. The primary objective is to assess the effects of gonyautoxins (PSP NEURO SERUM) on tactile sensitivity and safety on patients with CIPN. The study will be divided into two parts, 1 and 2 and the investigational treatment will have a maximum duration of 4 weeks (28 days).
Part 1 is a two-stage (stage 1 and stage 2), two-cohort (C1 and C2), open-label study where up to 38 pts with G>2 CIPN secondary to taxanes (C1) and other anti-neoplastic drugs (C2) will receive PSP NEURO SERUM thrice a day for 28 days. Twelve patients will be evaluated in stage 1, expecting a 20% response (2/12) in each cohort to proceed to stage 2. If needed, additional 7 patients will be recruited to stage, expecting 4/19 response in each cohort. If the number of responses is not met in a specific cohort, recruitment will be halted. The transition to the randomized part 2 will be determined by the efficacy in part 1 (stratified analysis of C1 and C2 or overall population).
The primary objective of Part 1 is to evaluate response of the tactile sensation as assessed by the Semmes-Weinstein monofilament test and to evaluate safety and toxicity (type, frequency, grade and causality of adverse effects) of PSP NEURO SERUM according to NCI-CTCAE v5.0.
The secondary objectives of Part 1 are to:
- Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score (TNSc)
- Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test (NHPT).
- Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire (PNQ).
- Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC Quality of Life Questionnaire (QLQ-C30)) version.
A patient will have responded to the CIPN in the study if there is a documented improvement of 30% (two sizes of evaluator) and / or normalization of the baseline pretreatment assessment as assessed by the Semmes-Weinstein monofilament test. A patient will have progressed CIPN in the study if there is a documented worsening in tactile sensation assessed by the Semmes-Weinstein monofilament test. Worse tactile sensation is defined as the change in one (1) size of the monofilament evaluator.
Part 2 of the study consists of two randomized groups of 26 patients each, one control group, and one experimental group, resulting in a total of 52 patients. The composition of the study population will follow an adaptive approach, considering which cohorts benefited the most from the effects of PSP NEURO SERUM in Part 1. Due to the greater benefit observed in cohort 1, we will proceed in Part 2 with only the population of patients who developed peripheral neuropathy secondary to taxanes.
The 52 patients will be allocated in a 1:1 ratio to either Arm A (control, n=26) or Arm B (experimental, n=26) with the objective of estimating and comparing the responses of tactile sensitivity using the Semmes-Weinstein monofilament test in hands caused by NPIQ. Patients in Arm A will receive a placebo (topical formulation composed of the same excipients without the active ingredient) three times a day for 28 days, and patients in Arm B will receive PSP NEURO SERUM (topical formulation) three times a day for 28 days.
This study will follow a two-stage randomized analysis approach with the expectation that the control group will have up to 20% response rate compared to 50% in the experimental group. An independent committee will assess and monitor the data collection results, allowing or disallowing the continuation of the analysis. The first stage will occur when both groups reach 50% of patients with complete validation, where a partial evaluation of necessary criteria will take place to proceed with data collection until reaching the required sample size for the final analysis (second stage).
In Part 2, patients with symptoms in their feet will be offered the possibility of using PSP NEURO SERUM/placebo on their lower limbs. The evaluation of symptoms will be assessed by extrapolation based on data collected by the EORTC QLQ CIPN20 Neuropathy Questionnaire.
The primary objective of Part 2 is to Evaluate tactile sensitivity response through the monofilament test of Semmes-Weinstein.
The secondary objectives of Part 2 are to:
- Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score (TNSc)
- Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test (NHPT).
- Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire (PNQ).EORTC CIPN20
- Assess safety and toxicity as per NCI-CTCAE v5.0 (National Cancer Institute - Common Toxicity Criteria For Adverse Events). Adverse events will be collected weekly and at the visit of safet/monitoring;
- Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC Quality of Life Questionnaire (QLQ-C30)) version.
The study procedures include:
- Screening Assessments (Part 1 and 2)
- Pre-treatment / Baseline Assessments (D1) (Part 1 and 2)
- D7 (± 1 day) - Assessments during Treatment (Part 1)
- D14 (± 1 day) - Assessments during Treatment (Part 1 and 2)
- D21 (± 1 day) - Assessments during Treatment (Part 1)
- End of Treatment (D28 + 3 days) (Part 1 and 2)
- Safety Follow-up Visit (30 ± 7 days from the last dose) (Part 1 and 2)
- Being tested
- PSP NEURO SERUM, Placebo PSP NEURO SERUM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSP NEURO SERUMDrug
PSP NEURO SERUM is a topical product that contains a concentration of Paralytic Shellfish Toxins of 10 micrograms/mL of equivalent of Gonyautoxin 2/3. Each patient will apply 1 g of PSP NEURO SERUM in their hands, three times a day.
Placebo PSP NEURO SERUMDrug
Placebo PSP NEURO SERUM is the same topical product as PSP NEURO SERUM without the active ingredient. Each patient will apply 1 g of Placebo PSP NEURO SERUM in their hands, three times a day.
| Study group | Role | What they receive |
|---|---|---|
| PSP NEURO SERUM | Active comparator | Active arm in which 26 patients will receive PSP NEURO SERUM in their hands three times a day for 28 days. Each application will consist of 1 g of PSP NEURO SERUM. Receives: Drug: PSP NEURO SERUM |
| Placebo of PSP NEURO SERUM | Placebo comparator | Placebo arm in which 26 patients will receive Placebo PSP NEURO SERUM (same ingredients as PSP NEURO SERUM except for the active ingredient that is replace with water) in their hands three times a day for 28 days. Each application will consist of 1 g of Placebo PSP NEURO SERUM. Receives: Drug: Placebo PSP NEURO SERUM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in response caused by PSP NEURO SERUM on the tactile sensation from baseline to day 28.
The response will be assessed using the Semmes-Weinstein monofilament test.
Measured: Screening and day 28
Secondary outcomes (5)
Evaluate the change in the overall neurological examination using the Total Neuropathy Score (TNSc), from baseline to day 28.
Evaluate the improvement of overall neurological examination as assessed by the clinical version of the Total Neuropathy Score (TNSc). The examination includes sensory symptoms, motors symptoms, autonomic symptoms, pin sensation, vibration sensibility, strength and tendon reflexes. The scores for each measurement goes from 0 to 4, being 0 a normal result and 4 an abnormal one.
Measured: Screening and day 28.
Evaluate the change of manipulative dexterity and agility from baseline to day 28.
Evaluate the improvement of manipulative dexterity and agility as assessed through the NHPT (Nine-hole Pegboard Test - test of nine pins and holes).
Measured: Screening and day 28.
Evaluate the change in patient reported symptoms from baseline to day 28.
Evaluate the improvement in patient reported symptoms as assessed by the EORTC CIPN20
Measured: Screening and day 28.
Evaluate the appearance of Adverse Events according to NCI-CTCAE v5.0 (National Cancer Institute - Commun Toxicity Criteria For Adverse Events).
Evaluate safety and toxicity (type, frequency, grade and causality of adverse effects) of PSP NEURO SERUM according to NCI-CTCAE v5.0.
Measured: Through the 28 days of the study
Evaluate the change in the quality of life from baseline to day 28.
Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) version.
Measured: Screening and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start14 Jan 2021
- Primary completion11 Jul 2024 (estimated)
- Study completion14 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 is a 2-stage, 2-cohort, open-label study where up to 38 pts with G\>2 CIPN secondary to taxanes and other anti-neoplastic drugs will receive PSP NEURO SERUM (PNS) thrice a day for 28 days. Twelve patients will be evaluated in stage 1, expecting a 20% response per cohort to proceed to stage 2. If needed 7 patients will be recruited, expecting 4/19 response in each cohort. If the number of responses is not met, recruitment will be halted. Part 2 consists of 2 randomized groups of 26 patients each, one control and one experimental group. The population will follow an adaptive approach, considering which cohorts benefited the most from the effects of PNS in Part 1. The 52 patients will be allocated in a 1:1 ratio to Arm A (control) or Arm B with the objective of estimating and comparing the responses of tactile sensitivity using the Semmes-Weinstein monofilament test in hands. Arm A will receive placebo 3 times/day for 28 days, and Arm B will receive PNS 3 times/day for 28 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algenis SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oncoclínicas
- Responsible party
- Principal investigator, Mariane Sousa Fontes Dias, Oncoclínicas
- Investigators
- Mariane Fontes, MD, Principal investigator, Oncoclínicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052398
- Sponsor's protocol ID
- Onco-2020
- Status last verified
- Jan 2024
- First submitted
- 10 Aug 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Principle Study Evaluating the Effects of Gonyautoxins, Paralytic Shellfish Poisoning (PSP) NEURO SERUM, on Objective and Subjective Symptoms of Chemotherapy-induced Peripheral Neuropathy (CINP)
- ClinicalTrials.gov ID
- NCT05052398
- Acronym / sponsor ID
- Onco-2020
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Algenis SpAIndustry (pharma, biotech, devices)
- Collaborators
- Oncoclínicas
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 11 Jul 2024 (estimated)
- Study completion
- 14 Jul 2025 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proof-of-concept study to assess the effects of gonyautoxins (PSP NEURO SERUM) on safety and tactile sensitivity on patients with chemotherapy-induced peripheral neuropathy (CIPN). This is a multicenter, prospective proof-of-concept study in patients with solid tumors affected by CIPN. The study will be divided into two parts: Part 1 will assess the activity and tolerability of PSP NEURO SERUM and part 2 consists of a randomized cohort that will compare the activity of PSP NEURO SERUM vs placebo. Part 2 will depend on the results of part 1. If there are less than 8 responses in part 1, the study will be interrupted, and it will not be recommended to proceed with part 2.
Detailed description
A multicenter, prospective proof-of-concept study in patients with solid tumors who developed chemotherapy-induced peripheral neuropathy (CIPN) in upper limbs, equal or greater than grade 2, according to NCI-CTCAE version 5.0. Patients must have been treated with cytotoxic agents known to cause CIPN in neoadjuvant, adjuvant or palliative setting. The primary objective is to assess the effects of gonyautoxins (PSP NEURO SERUM) on tactile sensitivity and safety on patients with CIPN. The study will be divided into two parts, 1 and 2 and the investigational treatment will have a maximum duration of 4 weeks (28 days).
Part 1 is a two-stage (stage 1 and stage 2), two-cohort (C1 and C2), open-label study where up to 38 pts with G>2 CIPN secondary to taxanes (C1) and other anti-neoplastic drugs (C2) will receive PSP NEURO SERUM thrice a day for 28 days. Twelve patients will be evaluated in stage 1, expecting a 20% response (2/12) in each cohort to proceed to stage 2. If needed, additional 7 patients will be recruited to stage, expecting 4/19 response in each cohort. If the number of responses is not met in a specific cohort, recruitment will be halted. The transition to the randomized part 2 will be determined by the efficacy in part 1 (stratified analysis of C1 and C2 or overall population).
The primary objective of Part 1 is to evaluate response of the tactile sensation as assessed by the Semmes-Weinstein monofilament test and to evaluate safety and toxicity (type, frequency, grade and causality of adverse effects) of PSP NEURO SERUM according to NCI-CTCAE v5.0.
The secondary objectives of Part 1 are to:
- Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score (TNSc)
- Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test (NHPT).
- Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire (PNQ).
- Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC Quality of Life Questionnaire (QLQ-C30)) version.
A patient will have responded to the CIPN in the study if there is a documented improvement of 30% (two sizes of evaluator) and / or normalization of the baseline pretreatment assessment as assessed by the Semmes-Weinstein monofilament test. A patient will have progressed CIPN in the study if there is a documented worsening in tactile sensation assessed by the Semmes-Weinstein monofilament test. Worse tactile sensation is defined as the change in one (1) size of the monofilament evaluator.
Part 2 of the study consists of two randomized groups of 26 patients each, one control group, and one experimental group, resulting in a total of 52 patients. The composition of the study population will follow an adaptive approach, considering which cohorts benefited the most from the effects of PSP NEURO SERUM in Part 1. Due to the greater benefit observed in cohort 1, we will proceed in Part 2 with only the population of patients who developed peripheral neuropathy secondary to taxanes.
The 52 patients will be allocated in a 1:1 ratio to either Arm A (control, n=26) or Arm B (experimental, n=26) with the objective of estimating and comparing the responses of tactile sensitivity using the Semmes-Weinstein monofilament test in hands caused by NPIQ. Patients in Arm A will receive a placebo (topical formulation composed of the same excipients without the active ingredient) three times a day for 28 days, and patients in Arm B will receive PSP NEURO SERUM (topical formulation) three times a day for 28 days.
This study will follow a two-stage randomized analysis approach with the expectation that the control group will have up to 20% response rate compared to 50% in the experimental group. An independent committee will assess and monitor the data collection results, allowing or disallowing the continuation of the analysis. The first stage will occur when both groups reach 50% of patients with complete validation, where a partial evaluation of necessary criteria will take place to proceed with data collection until reaching the required sample size for the final analysis (second stage).
In Part 2, patients with symptoms in their feet will be offered the possibility of using PSP NEURO SERUM/placebo on their lower limbs. The evaluation of symptoms will be assessed by extrapolation based on data collected by the EORTC QLQ CIPN20 Neuropathy Questionnaire.
The primary objective of Part 2 is to Evaluate tactile sensitivity response through the monofilament test of Semmes-Weinstein.
The secondary objectives of Part 2 are to:
- Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score (TNSc)
- Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test (NHPT).
- Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire (PNQ).EORTC CIPN20
- Assess safety and toxicity as per NCI-CTCAE v5.0 (National Cancer Institute - Common Toxicity Criteria For Adverse Events). Adverse events will be collected weekly and at the visit of safet/monitoring;
- Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC Quality of Life Questionnaire (QLQ-C30)) version.
The study procedures include:
- Screening Assessments (Part 1 and 2)
- Pre-treatment / Baseline Assessments (D1) (Part 1 and 2)
- D7 (± 1 day) - Assessments during Treatment (Part 1)
- D14 (± 1 day) - Assessments during Treatment (Part 1 and 2)
- D21 (± 1 day) - Assessments during Treatment (Part 1)
- End of Treatment (D28 + 3 days) (Part 1 and 2)
- Safety Follow-up Visit (30 ± 7 days from the last dose) (Part 1 and 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part 1 is a 2-stage, 2-cohort, open-label study where up to 38 pts with G>2 CIPN secondary to taxanes and other anti-neoplastic drugs will receive PSP NEURO SERUM (PNS) thrice a day for 28 days. Twelve patients will be evaluated in stage 1, expecting a 20% response per cohort to proceed to stage 2. If needed 7 patients will be recruited, expecting 4/19 response in each cohort. If the number of responses is not met, recruitment will be halted. Part 2 consists of 2 randomized groups of 26 patients each, one control and one experimental group. The population will follow an adaptive approach, considering which cohorts benefited the most from the effects of PNS in Part 1. The 52 patients will be allocated in a 1:1 ratio to Arm A (control) or Arm B with the objective of estimating and comparing the responses of tactile sensitivity using the Semmes-Weinstein monofilament test in hands. Arm A will receive placebo 3 times/day for 28 days, and Arm B will receive PNS 3 times/day for 28 days.
| Arm | Type | Receives |
|---|---|---|
| PSP NEURO SERUM | Active comparator | Drug: PSP NEURO SERUMActive arm in which 26 patients will receive PSP NEURO SERUM in their hands three times a day for 28 days. Each application will consist of 1 g of PSP NEURO SERUM. |
| Placebo of PSP NEURO SERUM | Placebo comparator | Drug: Placebo PSP NEURO SERUMPlacebo arm in which 26 patients will receive Placebo PSP NEURO SERUM (same ingredients as PSP NEURO SERUM except for the active ingredient that is replace with water) in their hands three times a day for 28 days. Each application will consist of 1 g of Placebo PSP NEURO SERUM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Age ≥18 years
- Histological diagnosis of cancer (hematologic or solid tumors).
- Part 1: Treatment with antineoplastic agents that induce peripheral neuropathy in neoadjuvant, adjuvant, or metastatic scenario; Part 2: Treatment with taxanes peripheral neuropathy inducers in the neoadjuvant, adjuvant, or metastatic scenario.
- Peripheral sensory neuropathy grade 2 or higher on upper limbs as per NCI-CTCAE v5.0. and with alteration of the Semmes Weinstein monofilament test.
Key exclusion criteria (25 listed)
- Prior treatment with gonyautoxins or any small molecule neurotoxins.
- Female participants who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or intend to become pregnant within 3 months.
- History of peripheral sensory neuropathy attributed to any cause other than chemotherapy.
- Patients receiving systemic treatment that has among its common side effects (> 1%) peripheral neuropathy, or who have received the same within the last 2 weeks. The use during the study of systemic drugs such as hormone therapy (e.g. tamoxifen, aromatase inhibitor, etc), or other agents that do not have among their common side effects (>1%) peripheral neuropathy, will be allowed.
- Patients with grade 2 CIPN with perceived improvement of symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSP NEURO SERUMPSP NEURO SERUM is a topical product that contains a concentration of Paralytic Shellfish Toxins of 10 micrograms/mL of equivalent of Gonyautoxin 2/3. Each patient will apply 1 g of PSP NEURO SERUM in their hands, three times a day. | Drug | PSP NEURO SERUM |
| Placebo PSP NEURO SERUMPlacebo PSP NEURO SERUM is the same topical product as PSP NEURO SERUM without the active ingredient. Each patient will apply 1 g of Placebo PSP NEURO SERUM in their hands, three times a day. | Drug | Placebo of PSP NEURO SERUM |
Primary outcome
Evaluate the change in response caused by PSP NEURO SERUM on the tactile sensation from baseline to day 28.
Time frame: Screening and day 28
The response will be assessed using the Semmes-Weinstein monofilament test.
5 secondary outcomes
Evaluate the change in the overall neurological examination using the Total Neuropathy Score (TNSc), from baseline to day 28.
Time frame: Screening and day 28.
Evaluate the change of manipulative dexterity and agility from baseline to day 28.
Time frame: Screening and day 28.
Evaluate the change in patient reported symptoms from baseline to day 28.
Time frame: Screening and day 28.
Evaluate the appearance of Adverse Events according to NCI-CTCAE v5.0 (National Cancer Institute - Commun Toxicity Criteria For Adverse Events).
Time frame: Through the 28 days of the study
Evaluate the change in the quality of life from baseline to day 28.
Time frame: Screening and day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariane Fontes, MD principal investigator
Oncoclínicas
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PSP NEURO SERUM in people with Chemotherapy-induced Peripheral Neuropathy, run by Algenis SpA at 9 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariane Fontes, MD (+55212127044, mariane.fontes@medicos.oncoclinicas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the change in response caused by PSP NEURO SERUM on the tactile sensation from baseline to day 28. (time frame: Screening and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.