Breast CancersNCT06819501
Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs
A study testing hyperbaric oxygenation treatment and routine care in people with Breast Cancers, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancers
- What is being tested?
- hyperbaric oxygenation treatment and routine care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 1 Sep 2026
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with newly diagnosed breast cancer by pathology
- Age 18-60 years
- ECOG 0-2
- CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs
Who cannot join
- Patients with contraindications to hyperbaric oxygen i. Untreated pneumothorax. ii. concomitant administration of disulfiram. iii. concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. iv. premature and/or low body mass newborns.
- Premature and/or low body mass neonates.
- Other cancers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Kun Wang, 13922118086, gzwangkun@126.com
About this study
The goal of this study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues
- Conditions
- Breast Cancers
- Being tested
- hyperbaric oxygenation treatment, routine care
- 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 oxygenation treatmentDevice
Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times.
routine careBehavioural
Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen group | Experimental | Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times and administration of pressurised ice gloves 30 minutes before, during and 30 minutes after the administration of paclitaxel-based chemotherapeutic agents. Receives: Device: hyperbaric oxygenation treatment; Behavioral: routine care |
| Control group | Active comparator | Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs. Receives: Behavioral: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in CIPN score due to paclitaxel analogues compared to baseline
Difference in change in CIPN score due to paclitaxel analogues compared to baseline
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
Secondary outcomes (9)
NPS degree
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
EORTC QLQ - CIPN20
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
ENS score
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
neuromyography
Measured: Baseline, 8 week
life quality
FACT-B Quality of Life Score
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
insomnia score
Insomnia Severity Index (ISI)
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
depression score
Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
Exhaustion score
Brief Fatigue Inventory (BFI)
Measured: Baseline, 2 week, 4 week, 6 week, 8 week
Side effects of hyperbaric oxygen therapy
Measured: during the hyperbaric oxygen therapy (up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start5 Feb 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819501
- Sponsor's protocol ID
- KY2024-1015-04
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs
- ClinicalTrials.gov ID
- NCT06819501
- Acronym / sponsor ID
- KY2024-1015-04
- Conditions
- Breast Cancers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 5 Feb 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 11 Feb 2025 (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 study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen group | Experimental | Device: hyperbaric oxygenation treatment, Behavioral: routine careAdministration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times and administration of pressurised ice gloves 30 minutes before, during and 30 minutes after the administration of paclitaxel-based chemotherapeutic agents. |
| Control group | Active comparator | Behavioral: routine careAdministration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed breast cancer by pathology
- Age 18-60 years
- ECOG 0-2
- CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs
Key exclusion criteria (3 listed)
- Patients with contraindications to hyperbaric oxygen i. Untreated pneumothorax. ii. concomitant administration of disulfiram. iii. concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. iv. premature and/or low body mass newborns.
- Other cancers
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 oxygenation treatmentAdministration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times. | Device | Hyperbaric Oxygen group |
| routine careAdministration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs. | Behavioural | Control group, Hyperbaric Oxygen group |
Primary outcome
Difference in change in CIPN score due to paclitaxel analogues compared to baseline
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
Difference in change in CIPN score due to paclitaxel analogues compared to baseline
9 secondary outcomes
NPS degree
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
EORTC QLQ - CIPN20
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
ENS score
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
neuromyography
Time frame: Baseline, 8 week
life quality
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
insomnia score
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
depression score
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
Exhaustion score
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week
Side effects of hyperbaric oxygen therapy
Time frame: during the hyperbaric oxygen therapy (up to 2 months)
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 11 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygenation treatment and routine care in people with Breast Cancers, run by Guangdong Provincial People's Hospital at 1 site 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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, Professor (86+13829694500, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in CIPN score due to paclitaxel analogues compared to baseline (time frame: Baseline, 2 week, 4 week, 6 week, 8 week). 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 11 Feb 2025.