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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hilotherapy | Experimental |
| |
| Standard care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hilotherapy | Device | Constant cooling device for hands and feet. |
|
| 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 |
| 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. |
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Most important Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
For a more detailed list, see protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Annemarie Coolbrandt, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Flemish-Brabant | 3000 | Belgium |
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Randomised controlled trial with stratification.
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| 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 |