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Effect van verwarmde oxaliplatin op acute perifere neuropathie klachten bij patienten die aanvullend of voor een gevorderde of uitgezaaide darmkanker behandeld worden met oxaliplatin houdende chemotherapie.

Recruiting
Conditions
acute peripheral neuropathy colorectal cancer oxaliplatin induced complaints
Registration Number
NL-OMON19943
Lead Sponsor
non
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
16
Inclusion Criteria

1. Patients treated adjuvant or palliative with oxaliplatin for a colon-rectal carcinoma who suffer from an acute peripheral neuropathy after the first treatment with oxaliplatin containing regime;

2. Living within a radius of 30 km from the hospital;

Exclusion Criteria

1. Presence of diabetes mellitus, renal failure, alcoholism, vitamin B 12 deficiency, other neoplasm or HIV;

2. Previous treatment with a neurotoxin cytostatic drug;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Decrease of the acute peripheral neuropathy complaints with 1 point or more on the four points scale of the Total Neuropathy Score;<br /><br>2. Changes in quality of life (cancer related and symptom related) in the period after infusion of heated oxaliplatin in comparison with the period after infusion of oxaliplatin on roomtemperature.
Secondary Outcome Measures
NameTimeMethod
Respons rate by CT scan and changes of CEA (tumormarker).
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