Not yet recruiting NCT07410169
Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric oxygen treatment, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Breast Cancer, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-induced Peripheral Neuropathy. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial
Overview
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.
Interventions
- Device Hyperbaric oxygen treatment
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) - Other Standard Care (in control arm)
Standard care
Primary outcome measures
- EORTC QLQ-CIPN20 subscales [Time frame: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.]
Secondary outcome measures (4)
- NCI-CTCAE 5.0 [Time frame: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended]
- EORTC QLQ-C30 [Time frame: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended]
- BPI-SF [Time frame: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended]
- Nerve Conduction Velocity [Time frame: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT07410169 · KY2026-046-02