Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy

Not Applicable

Completed

• Conditions: Quality of Life; Chemotherapy-induced Peripheral Neuropathy
• Interventions: Device: Hilotherapy

• Registration Number: NCT04913376
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2021-05-06
• Study Start: 2021-05-17
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-04
• Primary Completion: 2022-10-25
• Study Completion: 2022-10-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hilotherapy	Hilotherapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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").
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.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Flemish-Brabant, Belgium