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 objectThe…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
Decrease of the acute peripheral neuropathy complaints with 1 point or more on
the four points scale of the Total Neuropathy Score.
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
Secondairy endpoint:
Respons rate by CT scan en changes of CEA (tumormarker)
Background summary
Rationale:
Despite of the common preventive medication with calcium and magnesium,
eightyfive to ninety 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.
Study objective
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.
Study design
Study design:
A pilot study in 15 patients.
Intervention
Intervention:
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.
Study burden and risks
Before entering the study an 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.
Quality of life will be measured by the EORTC-QLQ-C30 and the QLQ-CIPN20
questionaire on 2 moments of each course.
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.
Koekoekslaan 1
3430 EM Nieuwegein
NL
Koekoekslaan 1
3430 EM Nieuwegein
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL29016.100.09 |
| OMON | NL-OMON19943 |