Breast CancerPhase 2/3NCT07410169
Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy
A Phase 2/3 study testing Hyperbaric oxygen treatment in people with Breast Cancer and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Guangdong Provincial People's Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-induced Peripheral Neuropathy
- What is being tested?
- Hyperbaric oxygen treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 29 Sep 2026to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wang Kun PhD, Doctor, 15989223200, gzwangkun@126.com
Kun Wang
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yingcong Lin, master of medicine, +86 18666885689, 18666885689@163.com
Kun Wang, PhD, +8613922118086, gzwangkun@126.com
About this study
Official title: Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial
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.
- Conditions
- Breast Cancer, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-induced Peripheral Neuropathy
- Being tested
- Hyperbaric oxygen treatment, Standard Care (in control arm)
- Keywords
- Breast Cancer, paclitaxel-Induced Peripheral Neuropathy, Hyperbaric Oxygen Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen treatmentDevice
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)
Standard Care (in control arm)Other
Standard care
| Study group | Role | What they receive |
|---|---|---|
| HBOT group | Experimental | 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) Receives: Device: Hyperbaric oxygen treatment |
| Control group | Other | Standard care Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-CIPN20 subscales
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
Measured: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
Secondary outcomes (4)
NCI-CTCAE 5.0
Patients will be assessed by professional physicians in accordance with the CTCAE Version 5.0 grading criteria. The evaluated items include peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia, myalgia, arthralgia, and neuralgia, each of which will be graded on a scale from Grade 0 to Grade 4
Measured: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
EORTC QLQ-C30
QoL was assessed with the EORTC QLQ-C30, which contains five functional scales, a global health status/QoL scale, three symptoms scales and six single items. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much', except for the global QoL scale that ranges from 1 'very poor' to 7 'excellent'. Scores were transformed to a 0-100 scale, where higher scores indicate better functional status and quality of life (QoL), whereas higher scores reflect more severe symptoms.
Measured: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
BPI-SF
Patient-reported pain severity and functional interference was assessed using the well-validated Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) includes four items that assess average, worst, least, and current pain severity over the past 24 hours. Each pain severity item is rated on an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Moreover, seven BPI items-assessing interference with daily activities/functions-are scored using the same 11-point scale (0 = does not interfere; 10 = completely interferes), consistent with established methodology. The seven items were summed to obtain a total interference score.
Measured: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
Nerve Conduction Velocity
Sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (SNCV) will be measured. The nerves measured included the tibial nerve, sural nerve, median nerve, and ulnar nerve.
Measured: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start29 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: In this group, patients will receive hyperbaric oxygen therapy at 2 absolute atmosphere, once a day, with each session lasting 90-120 minutes, for a total of 20-30 sessions. Control group: standard care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
- Investigators
- Kun Wang, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410169
- Sponsor's protocol ID
- KY2026-046-02
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07410169
- Acronym / sponsor ID
- KY2026-046-02
- Conditions
- Breast Cancer, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-induced Peripheral Neuropathy
- Keywords
- Breast Cancer, paclitaxel-Induced Peripheral Neuropathy, Hyperbaric Oxygen Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group: In this group, patients will receive hyperbaric oxygen therapy at 2 absolute atmosphere, once a day, with each session lasting 90-120 minutes, for a total of 20-30 sessions. Control group: standard care
| Arm | Type | Receives |
|---|---|---|
| HBOT group | Experimental | Device: Hyperbaric oxygen treatmenthyperbaric 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) |
| Control group | Other | Other: Standard Care (in control arm)Standard care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen treatmentPatients 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) | Device | HBOT group |
| Standard Care (in control arm)Standard care | Other | Control group |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kun Wang principal investigator
Guangdong Provincial People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyperbaric oxygen treatment in people with Breast Cancer and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Guangdong Provincial People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun Wang, PhD (+8615989223200, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-CIPN20 subscales (time frame: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.