Clinical trial NCT05531916: Compression Therapy as a Prophylactic Method Against CIPN: a Prospective Self-controlled Trial
Official title: Compression Therapy as a Prophylactic Method Against Paclitaxel-induced Peripheral Neuropathy: a Prospective Self-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Keywords: Paclitaxel
Compression therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.


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

Primary outcomes:
measure: Evaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)
timeFrame: Pretreatment (baseline=0), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.
Secondary outcomes:
measure: EORTC QLQ-CIPN20 score
timeFrame: Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.
measure: EORTC QLQ-C30 score
timeFrame: Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days), 3 and 6 months after chemotherapy completion.
measure: NRS score
timeFrame: Pretreatment（baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: