Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy

Taxane-induced Peripheral Neuropathy Clinical Trial

— ComPrendo  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464536
• Other study ID #: St.GallenU
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: St.Gallen University of Applied Sciences
• Contact: Anna Götz, PhD
• Phone: +41 43 253
• Email: anna.goetz[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: August 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Taxane-induced Peripheral Neuropathy

Intervention

Other:
• Compression
conventional surgical gloves that are commonly used in hospitals will be used for compression therapy of both hands

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St.Gallen University of Applied Sciences	University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peripheral polyneuropathy	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)	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	peripheral polyneuropathy patient reported outcome	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.	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	comfort of compression therapy	comfort will be measured with a 0 to 3 scale (0=not comfortable at all, 3=very comfortable)	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	adherence with compression therapy	percentage of time that compression should have been administered	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	Frequency of the application of manual abilities (like sewing, knitting, painting, playing the piano or similar)	Ordinal 1-item scale, ranging from from 0=never to 4=daily	at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)