Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

Not Applicable

Not yet recruiting

• Conditions: Breast Cancers

• Registration Number: NCT06819501
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study Start: 2025-02-05
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
neuromyography	Baseline, 8 week
NPS degree	Baseline, 2 week, 4 week, 6 week, 8 week
ENS score	Baseline, 2 week, 4 week, 6 week, 8 week
EORTC QLQ - CIPN20	Baseline, 2 week, 4 week, 6 week, 8 week
life quality	Baseline, 2 week, 4 week, 6 week, 8 week	FACT-B Quality of Life Score
depression score	Baseline, 2 week, 4 week, 6 week, 8 week	Hospital Anxiety and Depression Scale (HADS)
Exhaustion score	Baseline, 2 week, 4 week, 6 week, 8 week	Brief Fatigue Inventory (BFI)
Side effects of hyperbaric oxygen therapy	during the hyperbaric oxygen therapy (up to 2 months)
insomnia score	Baseline, 2 week, 4 week, 6 week, 8 week	Insomnia Severity Index (ISI)

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China