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

National University Health System (NUHS)

Status: Enrolling

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Device: Paxman Limb Cryocompression System (PLCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05606068

2022/00486

Details and patient eligibility

About

The study conducted on cancer patients is designed to test safety and efficacy of limb hypothermia in cancer patients using the new Paxman Limb Cryocompression System (PLCS). Ultimately this will lead to the development of a therapy regime that will help to prevent chemotherapy-induced neuropathy in cancer patients.

Full description

The study will consist of 80 cancer patients, recruited from the National University Hospital and Curie Oncology. Based on an established optimal temperature and pressure of limb cryocompression, cancer patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and efficacy 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: 80 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• Open skin wound or ulcers of the limbs
• History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
• Pregnant woman
• A score of more than 5 in Total Neuropathy Score (TNS) at baseline for cancer patients

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Cancer patients

Experimental group

Description:

Cancer patients will undergo limb cryocompression based on the established optimal temperature and pressure from previous studies over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.

Treatment:

Device: Paxman Limb Cryocompression System (PLCS)