A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO) (CINCAN-1)
1. september 2020 opdateret af: Zealand University Hospital
Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to discontinuation or omission of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.
This study will investigate the natural course of paclitaxel- and oxaliplatin induced peripheral neuropathy using novel diagnostic techniques. Multi-frequency vibrational technology has provided an objective method for the early detection of diabetic neuropathy. Our study will test the feasibility of this method within the field of clinical oncology and CIPN.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
32
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Roskilde, Danmark, 4000
- Department of Clinical Oncology and Palliative Care
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
We will invite patients to participate in conjuction with their standard treatment.
Patients have been diagnosed with ovarian cancer or colorectal cancer and have been scheduled to adjuvant treatment or metastatic treatment with one of the applicable drugs.
Beskrivelse
Inclusion Criteria:
- ≥ 18 years of age
- A diagnosis of cancer.
- Fulfil the criteria for starting chemotherapy.
- Scheduled to undergo at least 4 courses of paclitaxel- or oxaliplatin-based chemotherapy.
- No prior paclitaxel, oxaliplatin or other neurotoxic chemotherapy.
Exclusion Criteria:
- Unable to complete PRO measures.
- Previous neurotoxic chemotherapy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Paclitaxel
Patients scheduled to receive paclitaxel as part of their standard treatment
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We will observe the natural course of CIPN using multiple measurements
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Oxaliplatin
Patients scheduled to receive oxaliplatin as part of their standard treatment
|
We will observe the natural course of CIPN using multiple measurements
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in VPT from baseline to 6 mo.
Tidsramme: through study completion, an average of 1 year and 6 months
|
For patients receiving paclitaxel: Difference in vibrograms from baseline compared to vibrograms after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6).
|
through study completion, an average of 1 year and 6 months
|
|
Difference in VPT from Baseline to 4 mo.
Tidsramme: through study completion, an average of 1 year and 6 months
|
For patients receiving oxaliplatin: Difference in vibrograms from baseline compared to vibrograms after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no.
4).
|
through study completion, an average of 1 year and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in PRO from baseline and during 1. course chemotherapy.
Tidsramme: up to 5 days
|
Difference in the NCCTG-CIPN Questionnaire from baseline compared to 4 days after initiation of chemotherapy course no. 1.
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up to 5 days
|
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Difference in VPT from baseline and during 1. course chemotherapy
Tidsramme: up to 5 days
|
Difference in the Vibrograms from baseline compared to 4 days after initiation of chemotherapy course no. 1.
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up to 5 days
|
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Difference in PRO from baseline to after chemotherapy course no. 3
Tidsramme: through study completion, an average of 1 year and 6 months
|
For patients receiving paclitaxel: Difference in EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 3.
|
through study completion, an average of 1 year and 6 months
|
|
Difference in PRO from baseline to after chemotherapy course no. 2
Tidsramme: through study completion, an average of 1 year and 6 months
|
For patients receiving oxaliplatin: Difference in EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 2. Some patients receiving oxaliplatin will have 6 courses of planned chemotherapy or planned metastatic treatment, in this case comparison will be made after chemotherapy course no. 3.
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through study completion, an average of 1 year and 6 months
|
|
Difference in VPT from baseline to af chemotherapy course no. 3
Tidsramme: through study completion, an average of 1 year and 6 months
|
For patients receiving paclitaxel: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 3.
|
through study completion, an average of 1 year and 6 months
|
|
Difference in VPT from baseline to af chemotherapy course no. 2
Tidsramme: through study completion, an average of 1 year and 6 months
|
For patients receiving oxaliplatin: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 2. Some patients receiving oxaliplatin will have 6 courses of planned chemotherapy or planned metastatic treatment, in this case comparison will be made after chemotherapy course no. 3.
|
through study completion, an average of 1 year and 6 months
|
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No. of discontinuations
Tidsramme: through study completion, an average of 1 year and 6 months
|
Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered).
|
through study completion, an average of 1 year and 6 months
|
|
No. of dose reductions
Tidsramme: through study completion, an average of 1 year and 6 months
|
Number of patients that need reductions of chemotherapy dose (reasons will be registered)
|
through study completion, an average of 1 year and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. november 2019
Primær færdiggørelse (Forventet)
30. juni 2021
Studieafslutning (Forventet)
30. september 2021
Datoer for studieregistrering
Først indsendt
7. november 2019
Først indsendt, der opfyldte QC-kriterier
14. november 2019
Først opslået (Faktiske)
18. november 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REG-088-2019
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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