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Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

ConditionBreast Cancers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorGuangdong Provincial People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • routine care

    Behavioral

    Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: Hyperbaric Oxygen groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, 2 week, 4 week, 6 week, 8 week

Secondary outcomes

1

NPS degree

Time frame
Baseline, 2 week, 4 week, 6 week, 8 week
2

EORTC QLQ - CIPN20

Time frame
Baseline, 2 week, 4 week, 6 week, 8 week
3

ENS score

Time frame
Baseline, 2 week, 4 week, 6 week, 8 week
4

neuromyography

Time frame
Baseline, 8 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: