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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Active Comparator | Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric oxygenation treatment | Device | Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 2 week, 4 week, 6 week, 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| NPS degree | Baseline, 2 week, 4 week, 6 week, 8 week | |
| EORTC QLQ - CIPN20 | Baseline, 2 week, 4 week, 6 week, 8 week | |
| ENS score |
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Inclusion Criteria:
Exclusion Criteria:
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.
iv. Premature and/or low body mass neonates.
Other cancers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun wang, Professor | Contact | 86+13829694500 | gzwangkun@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| routine care | Behavioral | Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs. |
|
| Baseline, 2 week, 4 week, 6 week, 8 week |
| neuromyography | Baseline, 8 week |
| life quality | FACT-B Quality of Life Score | Baseline, 2 week, 4 week, 6 week, 8 week |
| insomnia score | Insomnia Severity Index (ISI) | Baseline, 2 week, 4 week, 6 week, 8 week |
| depression score | Hospital Anxiety and Depression Scale (HADS) | Baseline, 2 week, 4 week, 6 week, 8 week |
| Exhaustion score | Brief Fatigue Inventory (BFI) | Baseline, 2 week, 4 week, 6 week, 8 week |
| Side effects of hyperbaric oxygen therapy | during the hyperbaric oxygen therapy (up to 2 months) |
| D017437 |
| Skin and Connective Tissue Diseases |