A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy

National University Health System (NUHS)

Status: Unknown

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Device: Paxman Cryocompression System (PCCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05095051

2021/00288

Details and patient eligibility

About

The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.

Full description

The study consists of two parts. The first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. The occurrence or lack of core hypothermia will be studied. The second part of the study will consist of 15 cancer patients recruited from the National University Hospital. Patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.

Enrollment: 33 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. For healthy subjects:

   • Age 21-80 years
   • Signed informed consent from patient or legal representative
   • No history of neuropathy
   • ECOG 0
   • No history of hospitalization in the past 6 months

2. For cancer patients:

   • Age 21- 80 years
   • Signed informed consent from patient or legal representative
   • Scheduled to receive weekly paclitaxel chemotherapy
   • Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin.

Exclusion criteria

1. For healthy subjects:

   • Open skin wound or ulcers of the limbs
   • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
   • Pregnant women

2. For cancer patients:

   • Open skin wound or ulcers of the limbs
   • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
   • Pregnant women

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Healthy subjects

Experimental group

Description:

To assess safety and tolerability of limb cryocompression, as well as to determine the optimal temperature and pressure to be used. The occurrence or lack of core hypothermia will be studied.

Treatment:

Device: Paxman Cryocompression System (PCCS)

Device: Paxman Cryocompression System (PCCS)

Cancer patients

Experimental group

Description:

Once the optimal temperature and pressure of limb cryocompression is established in healthy subjects, a group of cancer patients will undergo limb cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.

Treatment:

Device: Paxman Cryocompression System (PCCS)

Device: Paxman Cryocompression System (PCCS)