HILO-OXALI: Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy
Study Details
Study Description
Brief Summary
Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hilotherapy
|
Device: Hilotherapy
Constant cooling device for hands and feet.
|
| No Intervention: Standard care
|
Outcome Measures
Primary Outcome Measures
- Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks [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.
Secondary Outcome Measures
- Secondary Outcome Measures regarding peripheral neuropathy (pro-ctcae) [24 weeks]
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.
- Secondary Outcome Measures regarding peripheral neuropathy (eortc-qlq-cipn20) [24 weeks]
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).
- Secondary Outcome Measures regarding pain in hands and feet (pro-ctcae) [24 weeks]
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.
- Secondary Outcome Measures regarding pain in hands and feet (eortc-qlq-cipn20) [24 weeks]
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.
- Secondary Outcome Measures regarding comfort hilotherapy [24 weeks]
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").
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Flemish-Brabant | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Annemarie Coolbrandt, PhD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S65284