Breast Cancers
Conditions
Brief 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
Interventions
DEVICEhyperbaric oxygenation treatment
Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times.
BEHAVIORALroutine care
Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly diagnosed breast cancer by pathology 2. Age 18-60 years 3. ECOG 0-2 4. CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs
Exclusion criteria
1. 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. 2. Other cancers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in change in CIPN score due to paclitaxel analogues compared to baseline | Baseline, 2 week, 4 week, 6 week, 8 week | Difference in change in CIPN score due to paclitaxel analogues compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ - CIPN20 | Baseline, 2 week, 4 week, 6 week, 8 week | — |
| ENS score | Baseline, 2 week, 4 week, 6 week, 8 week | — |
| neuromyography | Baseline, 8 week | — |
| life quality | Baseline, 2 week, 4 week, 6 week, 8 week | FACT-B Quality of Life Score |
| NPS degree | Baseline, 2 week, 4 week, 6 week, 8 week | — |
| depression score | Baseline, 2 week, 4 week, 6 week, 8 week | Hospital Anxiety and Depression Scale (HADS) |
| Exhaustion score | Baseline, 2 week, 4 week, 6 week, 8 week | Brief Fatigue Inventory (BFI) |
| Side effects of hyperbaric oxygen therapy | during the hyperbaric oxygen therapy (up to 2 months) | — |
| insomnia score | Baseline, 2 week, 4 week, 6 week, 8 week | Insomnia Severity Index (ISI) |
Countries
China
Contacts
Primary ContactKun wang, Professor
Outcome results
None listed