Chemotherapy-induced Peripheral Neuropathy, Quality of Life
Conditions
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.
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.
Interventions
DEVICEHilotherapy
Constant cooling device for hands and feet.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomised controlled trial with stratification.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium
Outcome results
None listed