Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy

NCT04913376 | Completed DMC

• 1 other identifier: S65284
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Secondary Outcome Measures regarding peripheral neuropathy (pro-ctcae)

  24 weeks

• Secondary Outcome Measures regarding peripheral neuropathy (eortc-qlq-cipn20)

  24 weeks

• Secondary Outcome Measures regarding pain in hands and feet (pro-ctcae)

  24 weeks

• Secondary Outcome Measures regarding pain in hands and feet (eortc-qlq-cipn20)

  24 weeks

• Secondary Outcome Measures regarding comfort hilotherapy

  24 weeks

Study Arms (2)

Hilotherapy

EXPERIMENTAL

Device: Hilotherapy

Standard care

NO INTERVENTION

Interventions

Hilotherapy DEVICE

Constant cooling device for hands and feet.

Hilotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)
• Starting oxaliplatin-based treatment

You may not qualify if:

• Already grade 2 or higher peripheral neuropathy
• For a more detailed list, see protocol.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Flemish-Brabant, 3000, Belgium

Location

Study Officials

• Annemarie Coolbrandt, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial with stratification.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: June 4, 2021
• Study Start: May 17, 2021
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)