Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

NCT06819501 · tracked via the Priya Life Science China tracker

Sponsor

Guangdong Provincial People's Hospital

Phase

Not applicable

Started

2025-02-05

Last updated

2025-02-11

Condition(s) studied

Breast Cancers

Investigational drug(s) / intervention(s)

hyperbaric oxygenation treatmentroutine care

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.

routine care: Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.

Study summary

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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: 1. Patients with newly diagnosed breast cancer by pathology 2. Age 18-60 years 3. ECOG 0-2 4. CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs Exclusion Criteria: 1. 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. 2. Other cancers

Primary outcome measure(s)

Difference in change in CIPN score due to paclitaxel analogues compared to baseline — Baseline, 2 week, 4 week, 6 week, 8 week
Difference in change in CIPN score due to paclitaxel analogues compared to baseline

Trial sites (1)

Facility	City	Region	Status
Guangdong Provincial People's Hospital	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819501 on ClinicalTrials.gov ↗ ← All trials in China