Acute peripheral neuropathy in patients treated with oxaliplatin; Is it possible to decrease the complaints?
Completed
- Conditions
- neuropathy10034606
- Registration Number
- NL-OMON33428
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Patients with advanced or metastatic colorectal carcinoma
Treatment with oxaliplatin containing regime
Acute peripheral neuropathy complaints after the first course with oxaliplatin
Living within a radius of 30 km from the hospital
Good understanding of the Dutch language
Exclusion Criteria
Presence of diabetes mellitus, renal failure, alcoholism, vitamin B 12
deficiency, other neoplasm or HIV.
Previous treatment with a neurotoxin cytostatic drug.
Already existing peripheral neuropathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints:<br /><br>Decrease of the acute peripheral neuropathy complaints with 1 point or more on<br /><br>the four points scale of the Total Neuropathy Score.<br /><br>Changes in quality of life (cancer related and symptom related) in the period<br /><br>after infusion of heated oxaliplatin in comparison with the period after<br /><br>infusion of oxaliplatin on roomtemperature. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondairy endpoint:<br /><br>Respons rate by CT scan en changes of CEA (tumormarker)</p><br>