Recruiting
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.
ClinicalTrials.gov IDNCT07410169
PhasePHASE2, PHASE3
Enrollment160
SponsorGuangdong Provincial People's Hospital
Age18 Years – 75 Years
SexFEMALE
Conditions studied
Breast Cancer, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-induced Peripheral Neuropathy
About this study
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 outcomes
- EORTC QLQ-CIPN20 subscales (baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.)
Eligibility information
Inclusion Criteria:
1. aged ≥ 18 years and ≤ 75 years, female
2. early-stage breast cancer or locally advanced breast cancer
3. Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel
4. 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.
5. The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.
Exclusion Criteria:
1. Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.
2. 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.
3. 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).
4. Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.
5. Karnofsky Performance Status score \< 80
6. Patients with any other conditions that the investigator deems unsuitable for participation in the study.
Study locations
- Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510080 China
- Guangdong Provincial People's Hospital, Guangzhou, Guangdong China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.