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Trial Title:
Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy
NCT ID:
NCT06464536
Condition:
Taxane-induced Peripheral Neuropathy
Conditions: Official terms:
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
All patients will wear surgical gloves, patients in the control group will wear gloves of
the correct size with a pressure less than 3 mmHg
Intervention:
Intervention type:
Other
Intervention name:
Compression
Description:
conventional surgical gloves that are commonly used in hospitals will be used for
compression therapy of both hands
Arm group label:
Compression group
Arm group label:
Control group
Other name:
Compression with surgical gloves
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 07/24 to 06/25.
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 FACT/COG-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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Mamma or Urogenital carcinoma
- first treatment with Taxanes (nab-Paclitaxel, Paclitaxel, Docetaxel)
- signed informed consent
- sufficient proficiency in German or English
Exclusion Criteria:
- other therapy that could have caused peripheral neuropathy within the last 24 months
(Taxane, Platin, Vincaalkaloids, etc.)
- History of neuropathy such as Raynaud's phenomenon, fibromyalgia and diabetic
polyneuropathy
- Use of polyneuropathy medications including duloxetine; gabapentin/pregabalin;
topical amitriptyline, ketamine, baclofen; oral cannabinoids; tricyclic
antidepressants; and ganglioside monosialic acid
- such impaired cognition that prevents participation in the study according to the
assessment of the caregivers
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2024
Completion date:
August 2025
Lead sponsor:
Agency:
St.Gallen University of Applied Sciences
Agency class:
Other
Collaborator:
Agency:
University of Zurich
Agency class:
Other
Source:
St.Gallen University of Applied Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464536
