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NCT Number: NCT06819501

Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

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

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Key information

Conditions

Breast Cancers Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperbaric oxygenation treatment

Device

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

Behavioral

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

Primary outcomes

  1. Difference in change in CIPN score due to paclitaxel analogues compared to baseline

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

    Difference in change in CIPN score due to paclitaxel analogues compared to baseline

Secondary outcomes

  1. NPS degree

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

  2. EORTC QLQ - CIPN20

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

  3. ENS score

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

  4. neuromyography

    Time frame: Baseline, 8 week

  5. life quality

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

    FACT-B Quality of Life Score

  6. insomnia score

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

    Insomnia Severity Index (ISI)

  7. depression score

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

    Hospital Anxiety and Depression Scale (HADS)

  8. Exhaustion score

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week

    Brief Fatigue Inventory (BFI)

  9. Side effects of hyperbaric oxygen therapy

    Time frame: during the hyperbaric oxygen therapy (up to 2 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Kun wang, Professor

CONTACT

[email protected]

86+13829694500

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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