Taxane-induced Peripheral Neuropathy
Conditions
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.
Interventions
OTHERCompression
conventional surgical gloves that are commonly used in hospitals will be used for compression therapy of both hands
Sponsors
University of Zurich
St.Gallen University of Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| peripheral polyneuropathy | at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days) | measured with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grades 0-4 : 0=none, 1=Asymptomatic; clinical or diagnostic observations only, 2=Moderate symptoms; limiting instrumental ADL; 3=Severe symptoms; limiting self care ADL; 4=Life-threatening consequences; urgent intervention indicated (i.e., higher scores meaning worse symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adherence with compression therapy | at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days) | percentage of time that compression should have been administered |
| peripheral polyneuropathy patient reported outcome | at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days) | measured with the neuropathy Subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group - Neurotoxicity (FACT/COG-NTX), The FACT-NTX subscale comprises 11 5-point ordinal scaled items (0=not at all to 4=very much). The points for each item are totaled and can range from 0=no symptoms to 44=severe symptoms. The participant is counted as a case if the change in the FACT-NTX reaches ≥5 points. |
| comfort of compression therapy | at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days) | comfort will be measured with a 0 to 3 scale (0=not comfortable at all, 3=very comfortable) |
| Frequency of the application of manual abilities (like sewing, knitting, painting, playing the piano or similar) | at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days) | Ordinal 1-item scale, ranging from from 0=never to 4=daily |
Countries
Switzerland
Contacts
Primary ContactAnna Götz, PhD
Backup ContactAntje Koller, PhD
Outcome results
None listed