Assessment of the responsiveness of the Rasch-built, CIPN-specific questionnaire (CIPN-RODS) to clinical changes in patients undergoing neurotoxic chemotherapy.

Assessment of the responsiveness of the Rasch-built, CIPN-specific questionnaire (CIPN-RODS) to clinical changes in patients undergoing neurotoxic chemotherapy. - Assessment of the CIPN-RODS in patients undergoing neurotoxic chemotherapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42804

Enrollment

Registered

2015-10-28

Start date

2016-05-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chemotherapy-induced polyneuropathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results