Clinical trial · Interventional
Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs
NCT06819501CI-TRIAL-00085747not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancers | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperbaric oxygenation treatment | Device | — | UNRESOLVED |
| routine care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperbaric Oxygen group
- description
- 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.
- interventionNames
- Device: hyperbaric oxygenation treatment
- Behavioral: routine care
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.
- interventionNames
- Behavioral: routine care
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.