Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy (HILO-OXALI)

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Hilotherapy

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Flemish-Brabant
    • Leuven, Flemish-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: Hilotherapy	Device: Hilotherapy; Constant cooling device for hands and feet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Annemarie Coolbrandt, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: S65284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No