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Decreasing acute peripheral neuropathy in patients treated with Oxaliplatin (heated oxaliplatin versus oxaliplatin on room temperature)

Decreasing acute peripheral neuropathy in patients treated with Oxaliplatin (heated oxaliplatin versus oxaliplatin on room temperature) - heated oxaliplatin versus oxaliplatin on room temperature

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32647
Enrollment
30
Registered
2009-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute peripheral neuropathy

Interventions

Intervention: Patients in the intervention group (arm A) receive warmed oxaliplatin, during a 2-hours infusion (temperature of 360 Celsius), patients in the control group (arm B) receive oxaliplati

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 - 70 years Treated with Oxaliplatin mono or in combination with other chemotherapeutical drugs or angiogenesis inhibitors. Adjuvant or palliative treatment for colorectal carcinoma Patients live within a radius of 30 km from the hospital

Exclusion criteria

Exclusion criteria: Patients with diabetes mellitus, renal failure, alcoholism, vitamin B 12 deficiency, other neoplasm and HIV. Patients who are treated in an early stage, with a cytostatic with a neurotoxicity profile. Patients with an already existing peripheral neuropathy Patients with congenital peripheral neuropathy

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: About 40% of the patients treated with oxaliplatin will suffer from acute peripheral neuropathy. This study will be successful if the complaints of patients in the intervention group can be reduced with 50%.

Secondary

MeasureTime frame
Secondary objects Is there a difference in severity of acute peripheral neuropathy and quality of life between the intervention and the standard group of patients? Is there a correlation between the severity of acute peripheral neuropathy and the quality of life in both groups

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)