Frozen gloves for prevention of chemotherapy-induced peripheral neuropathy

Phase 3

Completed

Conditions: chemotherapy-induced neuropathy
10034606

Registration Number: NL-OMON40077

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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