- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04913376
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Annemarie Coolbrandt, PhD
- E-mail: annemarie.coolbrandt@uzleuven.be
Undersøgelse Kontakt Backup
- Navn: Marie Vinckx, MSc
- Telefonnummer: +32 16 34 24 79
- E-mail: marie-astrid.vinckx@uzleuven.be
Studiesteder
-
-
Flemish-Brabant
-
Leuven, Flemish-Brabant, Belgien, 3000
- Rekruttering
- UZ Leuven
-
Kontakt:
- Coolbrandt Annemarie, PhD
- Telefonnummer: +3216341314
- E-mail: annemarie.coolbrandt@uzleuven.be
-
Kontakt:
- Vinckx Marie, MSc
- Telefonnummer: +3216342479
- E-mail: marie-astrid.vinckx@uzleuven.be
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Standard pleje
|
|
Eksperimentel: Hilotherapy
|
Constant cooling device for hands and feet.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Secondary Outcome Measures regarding peripheral neuropathy (pro-ctcae)
Tidsramme: 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.
|
24 weeks
|
Secondary Outcome Measures regarding peripheral neuropathy (eortc-qlq-cipn20)
Tidsramme: 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). |
24 weeks
|
Secondary Outcome Measures regarding pain in hands and feet (pro-ctcae)
Tidsramme: 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.
|
24 weeks
|
Secondary Outcome Measures regarding pain in hands and feet (eortc-qlq-cipn20)
Tidsramme: 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.
|
24 weeks
|
Secondary Outcome Measures regarding comfort hilotherapy
Tidsramme: 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").
|
24 weeks
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Annemarie Coolbrandt, PhD, UZ Leuven
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S65284
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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