Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

February 10, 2025 updated by: Kun Wang, Guangdong Provincial People's Hospital
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric Oxygen group
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.
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.
Active Comparator: Control group
Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.
Behavioral: routine care
Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 2 week, 4 week, 6 week, 8 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 5, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-1015-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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