|- candidate number||9299|
|- NTR Number||NTR2837|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-apr-2011|
|- Secondary IDs||NL29016.100.19 / R-09.16A; CCMO / VCMO St. Antonius Ziekenhuis|
|- Public Title||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.|
|- Scientific Title||Acute peripheral neuropathy in patients treated with oxaliplatin: Is it possible to decrease the complaints?
(Effect of heated oxaliplatin on acute peripheral neuropathy, a pilot study), September 2009.|
|- ACRONYM||Neuroxa studie|
|- hypothesis||Does heated oxaliplatin reduce the acute peripheral neuropathy complaints in patient with a colorectal carcinoma.|
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Acute peripheral neuropathy, Oxaliplatin induced complaints|
|- 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;
3. Good understanding of the Dutch language.
|- 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;
3. Already existing peripheral neuropathy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-mrt-2010|
|- planned closingdate||1-mei-2011|
|- Target number of participants||16|
|- Interventions||Oxaliplatin will be heated to a temperature of 36 degrees celsius during the 2-hours infusion period, irrespective the standard prophylaxis with magnesium and calcium.|
|- Primary outcome||1. Decrease of the acute peripheral neuropathy complaints with 1 point or more on the four points scale of the Total Neuropathy Score;|
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||Respons rate by CT scan and changes of CEA (tumormarker).|
|- Timepoints||1. Baseline TNS after course one with oxaliplatin;|
2. Just before, 48 hours and one week after two courses with heated oxaliplatin and one course with oxaliplatin on room temperature;
3. CEA, CT scans at baseline, 3 and 6 months after start chemotherapy.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A. Verbeek|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A. Verbeek|
|- Sponsor/Initiator ||Sint Antonius Ziekenhuis|
(Source(s) of Monetary or Material Support)
|St Antonius Hospital, Nieuwegein|
|- Brief summary||Rationale:|
Despite of the common preventive medication with calcium and magnesium, sixty to seventy percent of the patients treated with oxaliplatin for a colorectal carcinoma will suffer from an acute peripheral neuropathy. These complaints disable patients temporarily and therefore reduce their quality of live during the treatment with chemotherapy.
Main object: Is there a reduction of the acute peripheral neuropathy complaints of patients with advanced or metastatic colorectal cancer due to the infusion of heated oxaliplatin?
Does the quality of life of these patients improve?
Secondary object: The evaluation of the effectivity of the treatment.
A pilot study in 15 patients.
Patients treated adjuvant or palliative with oxaliplatin for a colon-rectal carcinoma who suffer from an acute peripheral neuropathy after the first treatment in het St. Antonius hospital of Nieuwegein/Utrecht (The Netherlands).
Oxaliplatin will be heated to a temperature of 36 degrees Celsius during the 2-hours infusion period, irrespective the standard prophylaxis with magnesium and calcium.
Main study parameters/endpoints:
Changes in the acute peripheral neuropathy complaints.
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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Before entering the study assessment of acute peripheral neuropathy will be carried out on two moments.
If acute peripheral neuropathy is diagnosed, patients will enter the study. During the second, third and fourth cycle of the chemotherapeutical regime the Total Neuropathy Score examination will be carried out on three moments.
If acute peripheral neuropathy is not diagnosed patients will not enter the study.
There is no physical risk or physiological discomfort to expect from the infusion of heated oxaliplatin.
|- Main changes (audit trail)|
|- RECORD||3-apr-2011 - 11-apr-2011|