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Effekt og sikkerhet av hyperbar oksygenbehandling for å bedre Nab-paclitaxel-indusert perifer nevropati

29. september 2026 oppdatert av: Kun Wang, Guangdong Provincial People's Hospital

Effekt og sikkerhet av hyperbar oksygenterapi for bedring av nab-paklitaksel-indusert perifer nevropati: En randomisert klinisk studie

The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

160

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Yingcong Lin, Master of Medicine
  • Telefonnummer: +8618666885689
  • E-post: 18666885689@163.com

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • Rekruttering
        • Guangdong Provincial People's Hospital
        • Ta kontakt med:
          • Kun Wang
        • Ta kontakt med:
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Guangdong Provincial People's Hospital
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  1. aged ≥ 18 years and ≤ 75 years, female
  2. early-stage breast cancer or locally advanced breast cancer
  3. Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel
  4. The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4/10.
  5. The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.

Exclusion Criteria:

  1. Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.
  2. Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.
  3. Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).
  4. Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.
  5. Karnofsky Performance Status score < 80
  6. Patients with any other conditions that the investigator deems unsuitable for participation in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: HBOT group

hyperbaric oxygen intervention：Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)
Enhet: Hyperbaric oxygen treatment

Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)
Annen: Control group

Standard care
Annen: Standard Care (in control arm)

Standard care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
EORTC QLQ-CIPN20 subscales
Tidsramme: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.

Self-reported neuropathy was assessed with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20, which contains 20 items divided into three subscales assessing sensory, motor and autonomic symptoms. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much'. Scores were transformed to a 0-100 scale, with higher scores representing more complaints
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
NCI-CTCAE 5.0
Tidsramme: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

Patients will be assessed by professional physicians in accordance with the CTCAE Version 5.0 grading criteria. The evaluated items include peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia, myalgia, arthralgia, and neuralgia, each of which will be graded on a scale from Grade 0 to Grade 4
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
EORTC QLQ-C30
Tidsramme: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

QoL was assessed with the EORTC QLQ-C30, which contains five functional scales, a global health status/QoL scale, three symptoms scales and six single items. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much', except for the global QoL scale that ranges from 1 'very poor' to 7 'excellent'. Scores were transformed to a 0-100 scale, where higher scores indicate better functional status and quality of life (QoL), whereas higher scores reflect more severe symptoms.
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
BPI-SF
Tidsramme: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

Patient-reported pain severity and functional interference was assessed using the well-validated Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) includes four items that assess average, worst, least, and current pain severity over the past 24 hours. Each pain severity item is rated on an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Moreover, seven BPI items-assessing interference with daily activities/functions-are scored using the same 11-point scale (0 = does not interfere; 10 = completely interferes), consistent with established methodology. The seven items were summed to obtain a total interference score.
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
Nerve Conduction Velocity
Tidsramme: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

Sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (SNCV) will be measured. The nerves measured included the tibial nerve, sural nerve, median nerve, and ulnar nerve.
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Guangdong Provincial People's Hospital

Etterforskere

  • Hovedetterforsker: Kun Wang, Guangdong Provincial People's Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

29. september 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

27. januar 2026

Først innsendt som oppfylte QC-kriteriene

7. februar 2026

Først lagt ut (Faktiske)

13. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY2026-046-02

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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