Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- EORTC QLQ-CIPN20 subscales
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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/
- •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.
Arms & Interventions
HBOT group
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)
Intervention: Hyperbaric oxygen treatment (Device)
Control group
Standard care
Intervention: Standard Care (in control arm) (Other)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Kun Wang
Professor
Guangdong Provincial People's Hospital