Hyperbaric oxygen therapy for nab-paclitaxel-induced neuropathy in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares hyperbaric oxygen therapy plus standard care to standard care alone in adults with nab-paclitaxel-induced peripheral neuropathy due to breast cancer treatment. It includes Phase 2 and Phase 3 components and uses patient-reported and clinician-assessed measures to gauge changes in neuropathy symptoms and quality of life. Eligible participants are women aged 18 to 75 with early or locally advanced breast cancer who completed nab-paclitaxel and developed neuropathy. Exclusion criteria include prior use of several neuropathy-targeting medications and other conditions that could confound neuropathy assessment. The study is led by Guangdong Provincial People's Hospital in Guangzhou, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Kun Wang — Guangdong Provincial People's Hospital
• Study coordinator: Kun Wang, PhD
• Email: gzwangkun@126.com
• Phone: +8615989223200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.