Skip to content

Acute peripheral neuropathy in patients treated with oxaliplatin; Is it possible to decrease the complaints?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33428
Enrollment
15
Registered
2009-10-15
Start date
2010-03-15
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

neuropathy

Interventions

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.

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondairy endpoint: Respons rate by CT scan en changes of CEA (tumormarker)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)