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

ConditionTaxane-induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt.Gallen University of Applied Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mamma or Urogenital carcinoma

first treatment with Taxanes (nab-Paclitaxel, Paclitaxel, Docetaxel)

signed informed consent

sufficient proficiency in German or English

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Compression

    Other intervention

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

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Compression groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
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

1

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.

Time frame
at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
2

comfort of compression therapy

comfort will be measured with a 0 to 3 scale (0=not comfortable at all, 3=very comfortable)

Time frame
at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
3

adherence with compression therapy

percentage of time that compression should have been administered

Time frame
at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
4

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

Time frame
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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St.Gallen University of Applied Sciences

Lead sponsor

University of Zurich

Collaborator

Source ClinicalTrials.gov
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