Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy

Study Overview
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Brief Summary
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Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial.

Detailed Description
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This study investigates whether constant cooling of the hands and feet using Hilotherm ChemoCare devices reduces the incidence of (severe) oxaliplatin-induced peripheral neuropathy and pain compared to standard care (i.e. no hand and foot cooling) in patients with gastrointestinal tumors.

Official Title
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Effectiveness of Hilotherapy for the Prevention of Oxaliplatin-induced Peripheral Neuropathy and Pain in the Treatment of Gastrointestinal Tumors: A Randomized Controlled Trial

Conditions
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Quality of Life, Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Device: Hilotherapy


Participation Criteria
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Eligibility Criteria
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Most important Eligibility Criteria: Inclusion Criteria: 18 years or older Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven) Starting oxaliplatin-based treatment Exclusion Criteria: Already grade 2 or higher peripheral neuropathy For a more detailed list, see protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial with stratification.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hilotherapy<br> | Device: Hilotherapy<br>* Constant cooling device for hands and feet.<br>|
| No Intervention: Standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks | Time-to-event analysis of Grade 2 or higher patient-reported peripheral neuropathy (severity scale, based on a patient-reported outcome questionnaire: Patient-Reported Outcomes for Adverse Events (PRO-CTCAE)). Outcome measurement value: percentage, absolute number, grade number. -- PRO-CTCAE: patient-reported outcome scale that assesses adverse events (e.g. pain and numbness & tingling) on severity (5-point Likert scale 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe) and interference with daily activities (0 = Not at all, 1 = A little bit, 2 = Somewhat, 3 = Quite a bit, 4 = Very much). We use the scale to assess the current experienced symptoms, and the scale has been translated to Dutch. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measures regarding peripheral neuropathy (pro-ctcae) | Time-to-event analysis and longitudinal analysis of a patient-reported outcome questionnaire (based on PRO-CTCAE: 4 items) and analysis of clinical decision-making to assess the incidence, severity and interference of peripheral neuropathy. Outcome measurement value: percentage, absolute number, grade number. This will be used to assess the cut-off point for the severity and interference experienced due to neuropathy. | 24 weeks | 
| Secondary Outcome Measures regarding peripheral neuropathy (eortc-qlq-cipn20) | Time-to-event analysis and longitudinal analysis of a PRO questionnaire (based on European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Chemotherapy-induced Peripheral Neuropathy 20 items (EORTC-QLQ-CIPN20)) and analysis of clinical decision-making to assess the incidence, severity and interference of peripheral neuropathy. Outcome measurement value: percentage, absolute number; to assess the degree of neuropathy in a more detailed way in comparison to the PRO-CTCAE. -- EORTC-QLQ-CIPN20: PRO scale that assesses 20 items (sensory (9), motor (8), autonomic symptoms (3)) with the use of a 4-point Likert scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). We use the scale to assess the current experienced symptoms, and the scale has been translated to Dutch. Sum score will be calculated by item 1-18 (item 19: driving ability; item 20: male impotence; seperate assessment). | 24 weeks | 
| Secondary Outcome Measures regarding pain in hands and feet (pro-ctcae) | Time-to-event analysis and longitudinal analysis of a PRO questionnaire (based on PRO-CTCAE: 4 items) and analysis of clinical decision-making to assess the incidence, severity and interference of pain in hands and feet. Outcome measurement value: percentage, absolute number, grade number. This will be used to assess the cut-off point for the severity and interference experienced due to pain in hands and feet. | 24 weeks | 
| Secondary Outcome Measures regarding pain in hands and feet (eortc-qlq-cipn20) | Time-to-event analysis and longitudinal analysis of a PRO questionnaire (based on European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Chemotherapy-induced Peripheral Neuropathy 20 items (EORTC-QLQ-CIPN20)) and analysis of clinical decision-making to assess the incidence, severity and interference of pain in hands and feet. Outcome measurement value: percentage, absolute number; to assess the degree of pain in hands an feet in a more detailed way in comparison to the PRO-CTCAE. | 24 weeks | 
| Secondary Outcome Measures regarding comfort hilotherapy | Descriptive analysis of a patient-reported outcome questionnaire to assess comfort and compliance of hilotherapy. Outcome measurement value: percentage, absolute number. Self-developed 5-point Likert scale to assess patient experiences with three items: hilotherapy cuffs, tolerance of temperature and impact on mobility during chemotherapy (1 = Very difficult, 2 = Difficult, 3 = Neutral, 4 = Comfortable, 5 = Very comfortable), and one specific question regarding patient experiences with the impact of hilotherapy on their experiences of numbness & tingling and pain during the administration of hilotherapy (1 = More severe, 2 = Less severe, 3 = Same experiences, 4 = No present experiences of numbness & tingling and pain). | 24 weeks |