Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464536
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-05
Brief Title:
Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy
Sponsor:
StGallen University of Applied Sciences
Organization:
StGallen University of Applied Sciences
Study Overview
Official Title:
Tight Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy A Randomized Controlled Trial to Evaluate the Efficacy of Compression Therapy in Patients With Taxane-based Chemotherapy for Breast and Urogenital Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ComPrendo
Brief Summary:
In this study the effect of compression therapy of the hands with tight surgical gloves to reduce peripheral neuropathy in adult patients during the application of taxanes will be evaluated
Detailed Description:
Chemotherapy-induced peripheral neuropathy CIPN is a common side effect of treatment with taxanes The damage to peripheral nerves leads to pain numbness and motor dysfunction which is very distressing for patients and often results in the reduction of the therapeutic dose of taxanes Preventive measures are limited but recent studies show that compression of the hands with tight surgical gloves can significantly reduce the incidence of CIPN The aim of this randomized controlled trial is to investigate the efficacy of compression therapy in reducing CIPN during taxane-based chemotherapy The randomized controlled and double-blind study will be conducted at the Comprehensive Cancer Center Zurich CCCZ of the University Hospital Zurich from 0724 to 0625 Participants will be recruited if they have breast cancer or a urogenital carcinoma and are receiving nab-paclitaxel paclitaxel or docetaxel Exclusion criteria include previous neurotoxic treatment existing neuropathy peripheral vascular disease or the use of medications that affect polyneuropathy The intervention group will wear surgical gloves with a compression pressure of 23-32 mmHg equivalent to compression class II for 30 minutes before during and 30 minutes after the infusion The control group will wear non-compressing gloves with a pressure of less than 3 mmHg The primary endpoint is the occurrence of moderate to severe CIPN within four therapy cycles measured according to NCI-CTCAE criteria Secondary endpoints include patient-reported symptoms and quality of life assessed by the FACTCOG-NTX questionnaire Comfort and adherence to the compression therapy will also be evaluated Participants will be randomized into two groups of 57 each Data collection and analysis will be conducted according to standardized procedures and the data will be securely and confidentially stored and managed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None