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Trial Title:
Compression Therapy as a Prophylactic Method Against CIPN: a Prospective Self-controlled Trial
NCT ID:
NCT05531916
Condition:
Nasopharyngeal Carcinoma
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Conditions: Official terms:
Nasopharyngeal Carcinoma
Peripheral Nervous System Diseases
Conditions: Keywords:
Paclitaxel
Compression therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The Account and IWRS end of the clinical trial randomization system of Sun Yat-sen
University Cancer Center (SYSUCC) randomly determined the limb (left or right) of the
participants to receive intervention, and the hand and foot on the same side were
classified into the same group during the randomization process.
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
Evaluator blind design was adopted, and all evaluations were made after the participants
had received the intervention and withdrawn the intervention. At this time, the blinded
evaluator did not know the tribal groups, while both the participants and researchers
knew the trial groups.
Intervention:
Intervention type:
Other
Intervention name:
Pressurized gloves and foot caps
Description:
Using pressurized gloves and foot caps in order to prevent chemotherapy-induced
peripheral neuropathy (CIPN).
Arm group label:
Group A
Summary:
This is a single-center, self-controlled, evaluator-blinded prospective study, which
applies pressurized gloves and foot caps to prevent paclitaxel-induced peripheral
neuropathy in patients with nasopharyngeal carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age range from 18 to 70
- ECOG physical status score: 0-2
- Newly diagnosed patients who have not received antitumor therapy
- Nasopharyngeal carcinoma confirmed by pathology
- Paclitaxel is included in the chemotherapy regimen
- Laboratory examination results within one week before enrollment should meet the
following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥80×109/L, total
bilirubin (TBI) ≤1.5× upper limit of normal value (2mg/ dL), ALT and AST ≤2× upper
limit of normal value
- Patients voluntarily participate and provide written informed consent
Exclusion Criteria:
- Patients with peripheral neuropathy, hand-foot syndrome, and dermatomyositis
- Patients with missing fingers or toes
- Patients with Raynaud's syndrome and peripheral vascular ischemia
- Pregnant or lactating women
- Those considered unsuitable for inclusion by the researcher
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunyan Chen, MD
Phone:
13826423812
Phone ext:
86
Email:
chenchuny@sysucc.org.cn
Start date:
November 21, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05531916
