Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral N… (NCT07410169) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy
China160 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EORTC QLQ-CIPN20 subscales
Timeframe: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
. 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.