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Not yet recruiting NCT06819501

Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

No phase Interventional Breast Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hyperbaric oxygenation treatment, routine care.
Who it may be relevant to
Registry conditions: Breast Cancers. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues

Interventions

  • Device hyperbaric oxygenation treatment
    Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times.
  • Behavioral routine care
    Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.

Primary outcome measures

  • Difference in change in CIPN score due to paclitaxel analogues compared to baseline [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
Secondary outcome measures (9)
  • NPS degree [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
  • EORTC QLQ - CIPN20 [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
  • ENS score [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
  • neuromyography [Time frame: Baseline, 8 week]
  • life quality [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
  • insomnia score [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
  • depression score [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
  • Exhaustion score [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week]
  • Side effects of hyperbaric oxygen therapy [Time frame: during the hyperbaric oxygen therapy (up to 2 months)]

Eligibility criteria

Inclusion criteria

  • Patients with newly diagnosed breast cancer by pathology
  • Age 18-60 years
  • ECOG 0-2
  • CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs

Exclusion criteria

  • Patients with contraindications to hyperbaric oxygen i. Untreated pneumothorax. ii. concomitant administration of disulfiram. iii. concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. iv. premature and/or low body mass newborns.

iv. Premature and/or low body mass neonates.

  • Other cancers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT06819501 · KY2024-1015-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗