Primary Objective: To define a core set of measures that meet clinimetric properties for being simple, valid, and reliable in CIPN.Secondary objectives: To develop an Overall Disability Sum-Score (ODSS) specific to CIPN; To develop a Responsiveness…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints: The primary endpoint for this study is to determine the validity and
reproducibility of the proposed outcome measures in chemotherapy-induced
peripheral neuropathy.
Trial Treatments: There are no trial-specified treatments as subjects will
receive only their usual medical care which must be stable during this study.
The investigators will not influence decisions regarding treatment duration nor
supply medication for this study.
Secondary outcome
not applicable
Background summary
The principal aim of this study is to evaluate through a multi-center
international collaboration among experienced neurologists and oncologists the
best method(s) available to assess and monitor chemotherapy-induced peripheral
neuropathy (CIPN).
Comparison between physician evaluation and subjects* subjective report of CIPN
severity using established questionnaires will be performed.
Study objective
Primary Objective: To define a core set of measures that meet clinimetric
properties for being simple, valid, and reliable in CIPN.
Secondary objectives:
To develop an Overall Disability Sum-Score (ODSS) specific to CIPN;
To develop a Responsiveness study based on the results of this study.
Study design
To assess inter-observer, intra-observer and test-retest studies, two
investigators in each participating centre will perform the selected impairment
and activity limitation scales in study subjects. Electrophysiological studies
will be performed only once at entry. One of the examiners will double-check
the questionnaires and scales prior to the departure of the subject. Subjects
will be examined at two different occasions at the outpatient clinics. During
the first visit the two examiners will perform their scores independently and
consecutively (usually within 2 hours) (inter-observer measures). Within 1-3
weeks, subjects will return for a second visit and both investigators will
re-examine the subject (intra-observer values) without having access to
previous examination findings. The outcome measures will be completed by the
subjects for a second time (test-retest examination).
Statistical Methods: Based on external expert opinion, the number of subjects
will be determined by a statistician using the current TNSc data and knowledge
of the number of centers in the two studies.
Correlation (Validity) studies will be generally performed using the Spearman
Rank correlation coefficient. In cases of multiple group analyses, one-way
analyses of variance with corrections according to Bonferroni
multiple-comparison tests will be performed. The Cronbach*s alpha coefficient
will be estimated in multi-item scales (adequacy criterion > 0.7). Other
reliability (test-retest, intra-observer, inter-observer) values for the
various outcome measures will be quantified by estimation of the intra-class
correlation coefficient using a one-way random effects analysis of variance
model as co-variable, and the different outcome measures as independent
variable.
Descriptive statistics will be used to summarize demographics and other
variables of interest.
Study burden and risks
Patients will be examined at the outpatient clinic twice with an interval of
1-3 weeks. Patients will be asked to complete questionnaires. This will take
about 1.5-2 hours per visit.
Postbus 5800
6201 AZ
Nederland
Postbus 5800
6201 AZ
Nederland
Listed location countries
Age
Inclusion criteria
1. Subjects must have CIPN and be available for study at a participating centre. CIPN is defined as having symptoms, signs and/or test results that in the opinion of the Investigator are typical of a toxic polyneuropathy due to the subject*s chemotherapy.
2. Male and female subjects who are 18 years of age or older.
3. Subjects must give 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.
5. Subjects must have a stable clinical condition. A clinical stable condition is defined as either an unchanged clinical functionality as declared by the subject to the best of his/her knowledge over 1 month prior to the study or no clear objective changes at neurological examination by the researcher when compared with recorded findings over two month prior to study entry (if available).
6. Each subject will receive an information leaflet and an informed consent form. A common version will be prepared in English and translated by each investigator in its own language.
7. Subjects must have a Karnofsky performance score greater than or equal to 70.
Exclusion criteria
Subjects presenting with any of the following will not be included in the trial:
1. Active underlying malignancy and poor prognosis.
2. Chemotherapy is planned while the subject is in this study.
3. Concomitant diseases e.g., diabetes, renal insufficiency, alcohol abuse (more than 5 IU/day) that would interfere or complicate the assessments.
4. Concomitant neurologic conditions, e.g., brain tumor, spinal or brain metastases that would interfere or complicate the assessments.
5. Severe depression that in the opinion of the Investigator would complicate the assessments.
6. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached.
7. Subjects with a known presence of peripheral nerve damage due to another illness or medication.
8. Subjects who are currently receiving another medication that has known potential to produce neurologic peripheral nerve toxicity, (e.g. metrodiazole or isoniazid).
9. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23064.068.08 |