Clinical trial NCT05606068: A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study
Official title: A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Chemotherapy-induced Peripheral Neuropathy
Cryocompression
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Paxman Coolers Ltd.
name: The N.1 Institute for Health, National University of Singapore
name: Curie Oncology, Mount Elizabeth Novena Specialist Centre
First posted: 2022-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cryocompression will be applied during every cycle of chemotherapy for a duration of up to 4 hours. All chemotherapy patients will receive 30 minutes pre-infusion cooling and 30 minutes post-infusion cooling. Cryocompression for each cycle will not exceed 4 hours. Chemotherapy and concomitant limb cryocompression are performed for 12 cycles and may be continued further in consultation with the PI. Overall, hypothermia will be administered for no longer than four hours.

Each patient will undergo maximum limb cooling. The initial device settings for the first cycle for each patient will be based on the optimal temperature determined to be safe and tolerable in previous studies. The temperature will be adjusted according to the patient's tolerance/intolerance feedback during each cycle of cooling and documented.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
timeFrame: 4 months
measure: Difference in qualitative symptom scores using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
timeFrame: 16 months
Secondary outcomes:
measure: PLCS usability questionnaire
timeFrame: 4 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Curie Oncology, Mount Elizabeth Novena Specialist Centre
Study officials:
affiliation: National University Hospital, Singapore
name: Si Jing, Joline Lim
role: PRINCIPAL_INVESTIGATOR
References:
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