Quality of LifeHILO-OXALINCT04913376
Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy
A study testing Hilotherapy in people with Quality of Life and Chemotherapy-induced Peripheral Neuropathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Hilotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 17 May 2021to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)
- Starting oxaliplatin-based treatment
Who cannot join
- Already grade 2 or higher peripheral neuropathy
- For a more detailed list, see protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Hilotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HilotherapyDevice
Constant cooling device for hands and feet.
| Study group | Role | What they receive |
|---|---|---|
| Hilotherapy | Experimental | Not described Receives: Device: Hilotherapy |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start17 May 2021
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with stratification.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemarie Coolbrandt, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913376
- Sponsor's protocol ID
- S65284
- Acronym
- HILO-OXALI
- Status last verified
- Jul 2024
- First submitted
- 6 May 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun 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.
PubMed 42435525
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hilotherapy for the Prevention of Oxaliplatin-induced Peripheral Neuropathy and Pain in the Treatment of Gastrointestinal Tumors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04913376
- Acronym / sponsor ID
- HILO-OXALI / S65284
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial with stratification.
| Arm | Type | Receives |
|---|---|---|
| Hilotherapy | Experimental | Device: Hilotherapy |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)
- Starting oxaliplatin-based treatment
Key exclusion criteria (2 listed)
- Already grade 2 or higher peripheral neuropathy
- For a more detailed list, see protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HilotherapyConstant cooling device for hands and feet. | Device | Hilotherapy |
Primary outcome
Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks
Time frame: 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.
5 secondary outcomes
Secondary Outcome Measures regarding peripheral neuropathy (pro-ctcae)
Time frame: 24 weeks
Secondary Outcome Measures regarding peripheral neuropathy (eortc-qlq-cipn20)
Time frame: 24 weeks
Secondary Outcome Measures regarding pain in hands and feet (pro-ctcae)
Time frame: 24 weeks
Secondary Outcome Measures regarding pain in hands and feet (eortc-qlq-cipn20)
Time frame: 24 weeks
Secondary Outcome Measures regarding comfort hilotherapy
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 42435525Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemarie Coolbrandt, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hilotherapy in people with Quality of Life and Chemotherapy-induced Peripheral Neuropathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.