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Frozen gloves for prevention of chemotherapy-induced peripheral neuropathy

Frozen gloves for prevention of chemotherapy-induced peripheral neuropathy - Frozen gloves for chemotherapy-induced neurotoxicity

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40077
Enrollment
140
Registered
2012-11-01
Start date
2013-02-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

chemotherapy-induced neuropathy

Interventions

None listed

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Written informed consent • Patients aged > 18 years • All cancer patients starting with paclitaxel, docetaxel or oxaliplatin • Understand Dutch language

Exclusion criteria

Exclusion criteria: • Patients with reported pre-existing neuropathy • Patients with cold intolerance • Patients with Raynaud*s syndrome • Patients earlier treated with paclitaxel, docetaxel or oxaliplatin • Patients using scalp cooling • Short-term chemoradiation with paclitaxel, docetaxel or oxaliplatin

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: Quality of life and neuropathy symptoms are measured with the validated European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORCT-QLQ) and with the validated CIPN20 self-report questionnaire respectively at four time points (begin study, after three cycles, end of chemotherapy and after 6 months).

Secondary

MeasureTime frame
Secundary objectives of the study are; 1) The degree of tolerance for the use of the frozen gloves measured with the numering rating scale (NRS) 2) Dose reduction due to neurotoxicity. 3) Difference in neurotoxicity expressed in the common toxicity criteria (CTC). 4) Clustering of symptoms: do patients also have complaints in the feet and are these similar to complaints of the hands?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)