Clinical trial NCT06464536: Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Taxane-induced Peripheral Neuropathy
Lead sponsor: St.Gallen University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2024-06-18
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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

Primary outcomes:
measure: peripheral polyneuropathy
timeFrame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
Secondary outcomes:
measure: peripheral polyneuropathy patient reported outcome
timeFrame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
measure: comfort of compression therapy
timeFrame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
measure: adherence with compression therapy
timeFrame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
measure: Frequency of the application of manual abilities (like sewing, knitting, painting, playing the piano or similar)
timeFrame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zuerich
Study officials:
affiliation: USZ
name: Anna Götz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St.Gallen University of Applied Sciences
name: Antje Koller, PhD
role: PRINCIPAL_INVESTIGATOR
References: