Primary Objective: to assess formally the responsiveness of a core set of measures derived from the previous CI-PeriNoms Study (Cavaletti, et al., 2013).Secondary objective: to test the responsiveness of the CIPN specific Rasch-built Overall…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The NCI-CTC v4 Sensory: The National Cancer Institute Common Toxicity Criteria
for Neuropathy sensory and motor has been the standard method of assessing
sensory neuropathy in most Oncology and industry based studies of CIPN. This
requires only a brief interview with the subject.
The Total Neuropathy Score© (TNS©): The TNS© is a composite neuropathy scale
captures neurological physical assessment in a much broader way (range: 0 - 40)
than oncological toxicity scales which usually range from 0 to 4 or 5.
The Douleur Neuropathique 4© (DN4©): The DN4© is one of the questionnaires that
can be useful in diagnosing neuropathic pain.
The Functional Assessment of Cancer Therapy - Gynecologic Oncology Group
Neurotoxicity© (FACT-GOG-NTX©): The FACT-GOG-NTX© is questionnaire to assess
quality of life of patients being treated with neurotoxic chemotherapy drugs.
PI-NRS and PGIC: Although not commonly reported, pain has been demonstrated in
CIPN and therefore we will be examining the presence and dynamics of pain
serially using the most frequently adopted simplistic scale, the Pain Intensity
Numeric Rating 11-point Scale (PI-NRS). In addition, the 7-points patient
reported global impression of change (PGIC) will also be registered (Farrar, et
al., 2001).
CIPN-RODS: The responsiveness of the CIPN-RODS will also be examined (Binda, et
al., 2013).
Electrophysiology: nerve conduction studies.
Secondary outcome
-
Background summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a major and dose-limiting
adverse event of a wide variety of chemotherapeutic agents including a number
of agents in development. CIPN is generally characterized by distal symmetrical
numbness, tingling, paresthesias, dysesthesias, pain and/or weakness which
significantly impacts subjects* functionality and quality of life (Cavaletti
and Zanna, 2002; Markman, 1996; Wenzel, et al., 2003). The incidence of CIPN
may be as high as 100% in treated patients, depending on dose and
dose-intensity of the chemotherapy regime. The neurotoxic side effects can be
permanent, and treatment is usually difficult. Neuro-protective agents are now
proposed that would either prevent or ameliorate CIPN without altering the
therapeutic benefits of the chemotherapeutic agent used. However, prior to
clinical trials of these agents, it is important to be able to assess CIPN in a
simple, valid, and reproducible manner in accordance with postulated
international guidelines (Hobart, et al., 1996; Streiner, 1998). Validity and
reliability are considered the minimum requirements for outcome measures prior
to their use in assessing any particular medical condition.
Study objective
Primary Objective: to assess formally the responsiveness of a core set of
measures derived from the previous CI-PeriNoms Study (Cavaletti, et al., 2013).
Secondary objective: to test the responsiveness of the CIPN specific
Rasch-built Overall Disability Scale (CIPN-RODS) derived from the previous
CI-PeriNoms study (Binda et al., 2013).
Study design
This is a longitudinal, international multi-center study.
The participant is expected to visit our hospital at least twice to undergo
several tests (neurological examination, EMG, filling out questionnaires). The
patient is expected for his first visit before the start of the chemotherapy.
Neurological examination will be carried out and several questionnaires will
be filled out. In addition, an EMG will be made. The second visit will take
place at the moment that a polyneuropathy is noted by the treating physician.
During this visit, only neurological examination and filling out the same
questionnaires as the first visit will be performed. So, if the patient does
not develop symptoms of polyneuropathy during the chemotherapeutic treatment,
this second visit will not take place. The last visit is immediately after the
end of the treatment with chemotherapy. Again, neurological examination will be
performed and a number of questionnaires is asked to fill out by the
participant. An EMG will also be performed.
Study burden and risks
All examinations (neurological examination, measurement of force / sense, the
EMG and questionnaires) do not have special risks.
Oxfordlaan 10
Maastricht 6202 AZ
NL
Oxfordlaan 10
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Subjects must be candidates for chemotherapy including in the treatment plan platinum-based drugs or taxanes at doses expected to be potentially neurotoxic
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 have a Karnofsky performance score greater than or equal to 70.
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.
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. Subjects with a known presence of peripheral nerve damage due to another illness or medication.
6. Subjects who are currently receiving another medication that has known potential to produce neurologic peripheral nerve toxicity (e.g. metrodiazole or isoniazid).
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 | NL53819.068.15 |