This randomized phase II open label study examines the effect of controlled cooling versus no cooling on the incidence and severity of oxaliplatin-induced peripheral neuropathy (OIPN) in patients treated with oxaliplatin.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in average relative dose intensity (expressed as a percentage of
the starting dose) of oxaliplatin in the control group compared to the
intervention group.
Secondary outcome
The scores of CIPN and EORTC QLQ-C30 scores are assessed for normality by
visually checking the difference scores with a histogram, and testing whether
the difference scores are normally distributed with the Shapiro-Wilk test. If
the data are normally distributed, the scores are compared with an unpaired
t-test. If the data are not normally distributed, the Mann-Whitney test is
used.
Background summary
A small-scale study recently proved that preventive controlled cooling can lead
to a decrease in chemotherapy-induced polyneuropathy (CIPN) in the hands and
feet, thereby preserving quality of life. Tergooi MC is the first hospital in
the Netherlands to include preventive controlled cooling as a standard
treatment for treatment with taxanes.
For treatment with oxaliplatin, there has recently been limited data that
controlled cooling can also reduce CIPN with this treatment. However, this has
only been proven in 1 small study and not in another independent cohort.
This randomized phase II open label study examines the effect of controlled
cooling versus no cooling on the incidence and severity of oxaliplatin-induced
peripheral neuropathy (OIPN) in patients treated with oxaliplatin.
Study objective
This randomized phase II open label study examines the effect of controlled
cooling versus no cooling on the incidence and severity of oxaliplatin-induced
peripheral neuropathy (OIPN) in patients treated with oxaliplatin.
Study design
The design of the study is a phase II open-label randomized controlled trial.
This research is carried out according to the GCP quality standard. Patients
eligible for treatment with oxaliplatin are asked to participate in the study.
With a randomization algorithm in Castor CDMS, patients are assigned to either
the intervention group or the control group (1:1 randomization stratification
will be based on oxaliplatin treatment schedule (80mg/m2 q2w versus 130mg/m2
q3w). ).
Similar to the study by Coolbrandt et al.
(https://doi.org/10.1016/j.esmoop.2023.101205), controlled cooling takes place
in the intervention group 30 minutes before the start, during running in and 30
minutes after running in the oxaliplatin.
Intervention
One group does not receive hand/foot cooling, one group receives controlled
hand/foot cooling
Study burden and risks
Risk of controlled hand/foot cooling is minimal.
Laan van Tergooi 2
Hilversum 1212 VG
NL
Laan van Tergooi 2
Hilversum 1212 VG
NL
Listed location countries
Age
Inclusion criteria
Treatment with oxaliplatin
Exclusion criteria
Presence of neuropathie before start treatment oxaliplatin;
previous chemotherapy treatment;
palliative treatment of pancreas- or stomachcarcinoma;
Raynaud's phenomenon
Cold-related conditions, including cryoglobulinemia, cold hemagglutination and
cold urticaria
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85337.018.23 |