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NCT Number: NCT07410169

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms CIPN - Chemotherapy-Induced Peripheral Neuropathy Neoplasms Neoplasms by Site Paclitaxel-induced Peripheral Neuropathy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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)

Standard Care (in control arm)

Other

Standard care

Primary outcomes

  1. EORTC QLQ-CIPN20 subscales

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

    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

Secondary outcomes

  1. NCI-CTCAE 5.0

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

    Patients will be assessed by professional physicians in accordance with the CTCAE Version 5.0 grading criteria. The evaluated items include peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia, myalgia, arthralgia, and neuralgia, each of which will be graded on a scale from Grade 0 to Grade 4

  2. EORTC QLQ-C30

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

    QoL was assessed with the EORTC QLQ-C30, which contains five functional scales, a global health status/QoL scale, three symptoms scales and six single items. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much', except for the global QoL scale that ranges from 1 'very poor' to 7 'excellent'. Scores were transformed to a 0-100 scale, where higher scores indicate better functional status and quality of life (QoL), whereas higher scores reflect more severe symptoms.

  3. BPI-SF

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

    Patient-reported pain severity and functional interference was assessed using the well-validated Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) includes four items that assess average, worst, least, and current pain severity over the past 24 hours. Each pain severity item is rated on an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Moreover, seven BPI items-assessing interference with daily activities/functions-are scored using the same 11-point scale (0 = does not interfere; 10 = completely interferes), consistent with established methodology. The seven items were summed to obtain a total interference score.

  4. Nerve Conduction Velocity

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

    Sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (SNCV) will be measured. The nerves measured included the tibial nerve, sural nerve, median nerve, and ulnar nerve.

Study contacts

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

Kun Wang, PhD

CONTACT

[email protected]

+8615989223200

Yingcong Lin, Master of Medicine

CONTACT

[email protected]

+8618666885689

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

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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