NCT06819501

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Feb 2025Sep 2026

First Submitted

Initial submission to the registry

January 21, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 11, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

January 21, 2025

Last Update Submit

February 10, 2025

Conditions

Breast Cancers

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline, 2 week, 4 week, 6 week, 8 week

Secondary Outcomes (9)

  • NPS degree

    Baseline, 2 week, 4 week, 6 week, 8 week

  • EORTC QLQ - CIPN20

    Baseline, 2 week, 4 week, 6 week, 8 week

  • ENS score

    Baseline, 2 week, 4 week, 6 week, 8 week

  • neuromyography

    Baseline, 8 week

  • life quality

    Baseline, 2 week, 4 week, 6 week, 8 week

  • +4 more secondary outcomes

Study Arms (2)

Hyperbaric Oxygen group

EXPERIMENTAL

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 treatmentBehavioral: routine care

Control group

ACTIVE COMPARATOR

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

Behavioral: routine care

Interventions

hyperbaric oxygenation treatmentDEVICE

Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times.

Hyperbaric Oxygen group
routine careBEHAVIORAL

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

Control groupHyperbaric Oxygen group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Kun wang, Professor

CONTACT

86+13829694500gzwangkun@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2025

First Posted

February 11, 2025

Study Start

February 5, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 11, 2025

Record last verified: 2025-01

Locations

CN(1)