Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Not yet enrolling

Conditions: Breast Cancers

Treatments: Behavioral: routine care; Device: hyperbaric oxygenation treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06819501

KY2024-1015-04

Details and patient eligibility

About

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

Enrollment: 226 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Hyperbaric Oxygen group

Experimental group

Description:

Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times and administration of pressurised ice gloves 30 minutes before, during and 30 minutes after the administration of paclitaxel-based chemotherapeutic agents.

Treatment:

Device: hyperbaric oxygenation treatment

Behavioral: routine care

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: routine care