A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Interventions
- Device: Paxman Limb Cryocompression System (PLCS)
- Registration Number
- NCT05606068
- Lead Sponsor
- National University Hospital, Singapore
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cancer patients Paxman Limb Cryocompression System (PLCS) 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.
- Primary Outcome Measures
Name Time Method 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 4 months Defined as the number of patients with treatment-related intolerance as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.
Difference in qualitative symptom scores using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale 16 months Difference in qualitative symptom scores using the EORTC QLQ-CIPN-20 scale before, at the end of paclitaxel chemotherapy with limb cryocompression, and at 3,6 and 12 months post-treatment.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) has 20 questions/items. This scale has a minimum of 1 and maximum of 4 for each of the 20 questions, with higher scores indicating a worse outcome.
- Secondary Outcome Measures
Name Time Method PLCS usability questionnaire 4 months PLCS usability questionnaire will be given to patients after completing all 12 cycles of chemotherapy with cryocompression, to determine the tolerance level and user experience. The PLCS usability questionnaire has a total of 8 questions, some of which use a scale of 1 to 5, while other questions use a scale of 1 to 10. Some questions differ with regard to whether higher scores mean a better or worse outcome, but majority of the questions have higher scores indicating a better outcome.
Trial Locations
- Locations (2)
National University Hospital
🇸🇬Singapore, Singapore
Curie Oncology, Mount Elizabeth Novena Specialist Centre
🇸🇬Singapore, Singapore