Limb cryocompression to prevent chemotherapy-related nerve damage
A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study
We will test whether cooling your arms and legs with the Paxman Limb Cryocompression System can prevent nerve damage in people with cancer receiving weekly paclitaxel chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Singapore, Singapore and 1 other locations) |
| Trial ID | NCT05606068 on ClinicalTrials.gov |
What this trial studies
This expansion study will enroll about 80 cancer patients at centers in Singapore to test repeated limb cryocompression over multiple cycles of weekly paclitaxel. Using the Paxman Limb Cryocompression System, cooling wraps will be applied from the digits to the elbow or knee at an established optimal temperature and pressure during chemotherapy infusions. Patients will be monitored for safety and signs of peripheral neuropathy over the treatment course. Key exclusions include open limb wounds, Raynaud's phenomenon, peripheral vascular disease, poorly controlled diabetes, pregnancy, and baseline neuropathy above the study cutoff.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21–80 who are scheduled to receive weekly paclitaxel, have a baseline Total Neuropathy Score of 5 or less, and do not have open limb wounds, Raynaud's, peripheral vascular disease, poorly controlled diabetes, or pregnancy.
Not a fit: Patients with open limb wounds, significant vascular disease or Raynaud's, poorly controlled diabetes, pregnancy, or baseline neuropathy above the study cutoff are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, this could reduce or prevent painful numbness and tingling in the hands and feet caused by taxane chemotherapy, helping patients preserve sensation and function.
How similar studies have performed: Previous small trials and case series of limb cooling or cryocompression for preventing chemotherapy-induced neuropathy have shown promising results, but larger randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore, Singapore and 1 other locations
- National University Hospital — Singapore, Singapore, Singapore (Recruiting)
- Curie Oncology, Mount Elizabeth Novena Specialist Centre — Singapore, Singapore, Singapore (Not_yet_recruiting)
Study contacts
- Principal investigator: Si Jing, Joline Lim — National University Hospital, Singapore
- Study coordinator: Si Jing, Joline Lim
- Email: joline_sj_lim@nuhs.edu.sg
- Phone: 6773 7888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.