Clinical trial · Interventional
Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy
Effectiveness of Hilotherapy for the Prevention of Oxaliplatin-induced Peripheral Neuropathy and Pain in the Treatment of Gastrointestinal Tumors: A Randomized Controlled Trial
NCT04913376CI-TRIAL-00078450HILO-OXALIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hilotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hilotherapy
- interventionNames
- Device: Hilotherapy
- type
- NO_INTERVENTION
- label
- Standard care
Primary outcomes (1)
- measure
- Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks
- timeFrame
- 12 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSun X, Fang Y, Yang X, Jiang J, Zhu L, Qian J, Shu P, Gu Y, Zhuang Z, Deng L, Hu W, Chen K, Jin C, Zuo Y, Xue D, Yang L, Jiang H, Shao C, Chen P, Zhu H, Yao M, Li L, Chen X, Li L, Cheng H. Neuroprotection and prevention of oxaliplatin-induced neuropathy with Huangqi Guizhi Wuwu Decoction: a 12-center randomized, double-blind trial with mechanistic validation. Phytomedicine. 2026 Sep;159:158539. doi: 10.1016/j.phymed.2026.158539. Epub 2026 Jul 1. PMID 42435525