Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2020-06-08
2025-12-31
Brief Summary
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Detailed Description
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Core study (assessments at baseline and at the end of treatment)
* Standard oncology assessment per local site
* NCI-CTC (national cancer institute common toxicity criteria) v.5 sensory and motor
* PRO-CTCAE (patient reported outcome-cancer common tocixity adverse event)
* PI-NRS (pain intensity numeric rating scale)
* NPS-CIN (Neuropathic Pain Scale for chemotherapy-induced neuropathy)
* EORTC CIPN20© (The European Organisation of Research and Treatment of. Cancer Quality of Life Questionnaire-CIPN twenty-item scale)
* FACT-GOG NTX v.4© (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity)
* TNSn© (total neuropathy score, nurse version)
* PGIC (patient global impression of change)
* OXA-NQ (oxaliplatin neurotoxicity questionnaire)
Extended study (at all available sites - any combination of assessment methods is allowed, minimum at baseline and at the end of treatment)
* EORTC CIPN15
* CIPN-R-ODS (CIPN Rash overall disability scale)
* TNSc© at the same time points as for questionnaire
* OXA-NQ (also at mid-treatment)
* nerve conduction study of the radial (motor and sensory), ulnar (motor and sensory), sural, dorsal sural and common peroneal nerves (\*)
* QST (\*) \[quantitative sensory testing\]
* Serum for biomarkers search (\*)
* DN4
Rationale: Within a multi-center international collaboration among experienced neurologists, oncologists, nurses and symptom scientists, the principal aim of this study is to evaluate responsiveness of a set of outcome measures for CIPN evaluation in order to define the gold standard for its assessment.
The assessment of CIPN will be performed at different levels of investigation. The Core study will allow the evaluation of subjects with common devices, so that an assessment can be performed at any medical site (expected time for questionnaires completion 15 minutes).
The Extended study will add any combination of the listed assessment methods/biological sample collection, in order to ascertain whether this approach can provide a more careful and clinically-relevant estimate of the peripheral nervous system damage. Comparison between healthcare evaluation and subjects' report of CIPN severity using established questionnaires will be performed in both Core and Extended studies.
Aims: The primary aim for this study is to test responsiveness of the different assessment methods used in the core study, in a multi-center, multi-regional International setting, comparing changes from baseline to end of treatment. Secondary aims are:
* to evaluate responsiveness (changes from base line to end of treatment) also of the other outcome measures used in the Extended Study;
* to evaluate mid-treatment data predictiveness of end of treatment neurological status for each outcome measure;
* to evaluate recovery rate/modification of the neurological status for the follow up evaluations (3/6/12/24 months after treatment), stratifying data for different drugs.
Study Design: 1000 patients who are candidates for neurotoxic chemotherapy for any cancer with non-investigational drugs (including immune checkpoint inhibitors and "targeted" drugs) will be enrolled from participating centers. A trained investigator in each participating center will perform the selected healthcare-assessed scales and supervise the patient-completed measures as presented in Table 1. Subjects will be examined at least at baseline and end of treatment (Core Study) and at additional intermediate and follow-up timepoints (Extended study), according to their treatment plan.
Study Treatments: There are no study-specified treatments, as subjects will receive only their standard of care chemotherapy. The investigators will not influence decisions regarding treatment duration nor supply medication for this study. However, all treatment regimens will be registered.
Participating Centers minimum requirements: Participating Centers should:
1. accept the study protocol and have their participation approved by a local Ethics Committee/Institutional Review Board
2. have access through an internet connection to the secure server located at the main site
3. guarantee the proper assessment of the selected patients at least at the Core study level
4. have the potential to recruit at least 30 patients/year
5. have the capacity to upload the data collected from each patient within 1 week
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients who are receiving a neurotoxic chemotherapy
List of neurotoxic drugs eligible for enrolment
* Platinum drugs
* Taxanes
* Vinca alkaloids
* Epothilones
* Proteasome inhibitors
* Thalidomide
* Vedotin-based drugs
* checkpoint inhibitors
* Any combination of the aforementioned drugs
outcome measures for CIPN testing
questionnaires administration, physician based scales for CIPN data collection
Interventions
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outcome measures for CIPN testing
questionnaires administration, physician based scales for CIPN data collection
Eligibility Criteria
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Inclusion Criteria
2. Male and female subjects who are 18 years of age or older.
3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
Exclusion Criteria
1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
2. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
3. Severe depression that in the opinion of the Investigator would complicate the assessments.
4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
5. Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).
6. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g. metronidazole, isoniazid, amiodarone, antiretroviral medications).
7. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
8. Previous neurotoxic chemotherapy.
18 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Responsible Party
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Principal Investigators
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GUIDO CAVALETTI, MD
Role: STUDY_CHAIR
University of Milano Bicocca
PAOLA ALBERTI, MD
Role: PRINCIPAL_INVESTIGATOR
University of Milano Bicocca
Locations
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Birmingham School of Nursing, University of Alabama
Birmingham, Alabama, United States
Northside Hospital
Atlanta, Georgia, United States
JHU
Baltimore, Maryland, United States
University of Michigan School of Nursing
Ann Arbor, Michigan, United States
Columbia University Irving Medical Center
New York, New York, United States
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division
Columbus, Ohio, United States
Dartmouth-Hitchcock Medical Center
Lebanon, Pennsylvania, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Brain and Mind Center
Sydney, , Australia
Dept. of Neurology, Medical University of Vienna
Vienna, , Austria
International Centre for Diarrhoeal Disease Research
Dhaka, , Bangladesh
Clínica AMO
Salvador, , Brazil
The Ottawa Hospital
Ottawa, , Canada
Aarhus University Hospital
Aarhus, , Denmark
Hôpital Percy
Clamart, , France
CHU Dupuytren
Limoges, , France
Center for Molecular Medicine
Cologne, , Germany
University of Larissa
Larissa, , Greece
"Saint Andrew's" State General Hospital
Pátrai, , Greece
San Gerardo Hospital
Monza, Mb, Italy
Ospedale Valduce
Como, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
A.O.U. Policlinico "G. Martino"
Messina, , Italy
Padova Hospital
Padua, , Italy
Azienda Ospedaliera Universitaria
Verona, , Italy
Medical Oncoloy Unit - University of Nairobi
Nairobi, , Kenya
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, , Portugal
Dong-A University - Internal Medicine Dept.
Busan, , South Korea
Hospital Universitari de Bellvitge-ICO L'Hospitalet
Barcelona, , Spain
University of Basel - Department of Sport, Exercise and Health
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Margaret Ferreira
Role: backup
Other Identifiers
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ICAVS
Identifier Type: -
Identifier Source: org_study_id
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