- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07638774
The Efficacy of Compression/Ice Gloves/Socks in Patients With UTD1-induced Neuropathy.
Reducing Peripheral Sensory and Motor Neuropathy Induced by UTD1 With Compression/Ice Gloves/Socks, a Multi-center Prospective Phase III Trial (YBCSG-20-02).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Xichun Hu, MD,Phd
- Telefonnummer: 13816110335
- E-post: xchu2009@hotmail.com
Studera Kontakt Backup
- Namn: Jian Zhang, MD,Phd
- Telefonnummer: 18017312991
- E-post: zhangjian1001@csco.ac.cn
Studieorter
-
-
-
Shanghai, Kina
- Rekrytering
- Fudan University Shanghai Cancer Center
-
Kontakt:
- Jian Zhang, PHD
- Telefonnummer: 021-64175590
- E-post: syner2000@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Female ,18-75 years;
- Documentation of histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer;
- The participants is going to receive UTD1 based regimen at least 2 cycles;
- The baseline peripheral sensory neuropathy and peripheral motor neuropathy (CTCAE 5.0) is less than 1 grade;
- ECOG score ≤1;
Adequate organ and bone marrow function defined as follows within 7 days before enrollment:
Absolute Neutrophil Count (ANC) ≥1,500/mm 3 (1.5 ×10 9/L), white blood cell count (WBC) ≥3.5×10 9/L, platelets ≥75,000/mm 3 (75×10 9/L), hemoglobin ≥9 g/dL (90 g/L), no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulation factor within 7 days.
Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); AST, ALT, ALP exceeding the upper limit of normal but ≤ 2.5 × ULN when no liver metastasis; AST, ALT, ALP exceeding the upper limit of normal but ≤ 5 × ULN when liver metastasis.
- Expected survival time ≥12 weeks;
- No history of serious heart, lung, liver, kidney and other important organ diseases;
- Signed informed consent;
- Good compliance to the protocol;
- Women of childbearing age must already be using reliable contraception, a pregnancy test (blood or urine) is performed within 14 days before enrollment and the result was negative (if positive, pregnancy must be ruled out by ultrasound), and willing to use an appropriate methods of contraception during the trial and for 8 weeks after completion of the trial.
Exclusion Criteria:
- Previous treatment of UTD1;
- Severe uncontrolled infection.
- Patients with leptomeningeal metastases, symptomatic brain metastases, spinal cord compression, or brain or leptomeningeal disease detected on imaging at screening (patients who had completed local brain therapy 21 days before treatment and had stable symptoms and no cerebral hemorrhage confirmed by imaging were eligible).
- Patients whose hands/feet are not suitable for wearing the compression/ice gloves/socks;
- Other conditions unsuitable for the enrollment, including but not limited to illiteracy, inability to complete the peripheral neurotoxicity scale, and other neurological abnormalities affecting the accurate assessment of neurotoxicity, etc.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: blank control group
No intervention.
|
|
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Experimentell: compression glove/sock group
Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
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Experimentell: ice glove/sock group
Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment
Tidsram: 6 weeks
|
6 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in incidence of total peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
Tidsram: 6 weeks
|
6 weeks
|
|
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Difference in the incidence of ≥grade 2 peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
Tidsram: 6 weeks
|
6 weeks
|
|
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Difference in incidence of total peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
Tidsram: 6 weeks
|
6 weeks
|
|
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Differences in peripheral neurotoxicity scale scores assessed by Functional Assessment of Cancer Therapy-breast after 2 cycles of UTD1 treatment.treatment.
Tidsram: 6 weeks
|
6 weeks
|
|
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Number of participants with device-related adverse events
Tidsram: 6 weeks
|
Number of participants experiencing adverse events related to the use of cryotherapy gloves/socks or compression gloves/socks, including skin injury, pain, discomfort, cold intolerance, numbness, and other device-related adverse events, assessed according to CTCAE v5.0.
|
6 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ting Li, fudan university shanghai cancer center shanghai, China
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- YBCSG-20-02
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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