An interventional study of Hypothermia and Cryocompression in Chemotherapy-induced Peripheral Neuropathy (CIPN), sponsored by National University Hospital, Singapore. Completed. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-03.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Prevention
The project is designed to study the use of localized hypothermia alone, or with compression to the limbs during chemotherapy infusion for the prevention of chemotherapy induced peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical activity will be studied. The study will be conducted on healthy volunteers and cancer patients receiving taxane chemotherapy.
Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable methods for the prevention or the treatment of CIPN. On the basis of the dose-related pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would aim to reduce the development of CIPN. This project comprises of a healthy subject trial to investigate the best tolerated temperature which will be used in cancer subject trial to investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.
The inclusion criterion for the healthy subjects
The inclusion criteria for the cancer patients undergoing taxane-based chemotherapy
The exclusion criteria for both healthy subjects and cancer patients
To investigate the safety and tolerability of limb hypothermia in subjects without cancer
Device: Hypothermia
To investigate the safety and tolerability of cryocompression in subjects without cancer
Device: Cryocompression
To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.
Device: Hypothermia
To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.
Device: Cryocompression
Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.
Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.
Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
Time frame: From the start of assessment until study completion, an average of 3 years
Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
Time frame: From the start of assessment until study completion, an average of 3 years
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peripheral Nervous System Diseases→
National University Hospital, Singapore