Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy

NCT07410169 | Not Yet Recruiting Phase 2

• 1 other identifier: KY2026-046-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.

Conditions

Breast Cancer; CIPN - Chemotherapy-Induced Peripheral Neuropathy; Paclitaxel-induced Peripheral Neuropathy

Keywords

Breast Cancer; paclitaxel-Induced Peripheral Neuropathy; Hyperbaric Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• EORTC QLQ-CIPN20 subscales

  Self-reported neuropathy was assessed with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20, which contains 20 items divided into three subscales assessing sensory, motor and autonomic symptoms. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much'. Scores were transformed to a 0-100 scale, with higher scores representing more complaints

  baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.

Secondary Outcomes (4)

• NCI-CTCAE 5.0

  baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

• EORTC QLQ-C30

  baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

• BPI-SF

  baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

• Nerve Conduction Velocity

  baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended

Study Arms (2)

HBOT group

EXPERIMENTAL

hyperbaric oxygen intervention：Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)

Device: Hyperbaric oxygen treatment

Control group

OTHER

Standard care

Other: Standard Care (in control arm)

Interventions

Hyperbaric oxygen treatment DEVICE

Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)

HBOT group

Standard Care (in control arm) OTHER

Standard care

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥ 18 years and ≤ 75 years, female
• early-stage breast cancer or locally advanced breast cancer
• Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel
• The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4/10.
• The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.

You may not qualify if:

• Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.
• Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.
• Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).
• Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.
• Karnofsky Performance Status score \< 80
• Patients with any other conditions that the investigator deems unsuitable for participation in the study.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kun Wang

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Wang, PhD

CONTACT

+8615989223200; gzwangkun@126.com

Yingcong Lin, Master of Medicine

CONTACT

+8618666885689; 18666885689@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention group: In this group, patients will receive hyperbaric oxygen therapy at 2 absolute atmosphere, once a day, with each session lasting 90-120 minutes, for a total of 20-30 sessions. Control group: standard care

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 13, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)