CompletedNot Applicable

PREventing CHemotherapy Induced Neuropathy (PreChIN)

89 participantsStarted 2013-06-13

Plain-language summary

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.

Who can participate

Age range21 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

The inclusion criterion for the healthy subjects * Age 21-80 years * Signed informed consent from patient * No history of neuropathy * ECOG 0 * No history of hospitalization in the past 6 months The inclusion criteria for the cancer patients undergoing taxane-based chemotherapy * Age 21- 80 years. * Signed informed consent from patient or legal representative. * Scheduled to receive taxane-based chemotherapy The exclusion criteria for both healthy subjects and cancer patients * Open skin wound or ulcers of the limbs * A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (Not applicable for healthy subjects) * History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes

What they're measuring

Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression

Timeframe: 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

Timeframe: From the start of assessment until study completion, an average of 3 years

Trial details

NCT IDNCT03299582

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11-03

View on ClinicalTrials.gov More Chemotherapy-induced Peripheral Neuropathy (CIPN) trials

Plain-language summary

Who can participate

Age range21 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression

Timeframe: 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

Timeframe: From the start of assessment until study completion, an average of 3 years