Compression Therapy as a Prophylactic Method Against CIPN: a Prospective Self-controlled Trial

NCT ID: NCT05531916

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma CIPN - Chemotherapy-Induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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blind design was adopted, and all evaluations were made after the participants had received the intervention and withdrawn the intervention.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.

Study Groups

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Group A

Participants wear pressurized gloves and foot caps for 15 minutes before their chemotherapy treatment, during the treatment, and for 15 minutes after it ended.

Group Type EXPERIMENTAL

Pressurized gloves and foot caps

Intervention Type OTHER

Using pressurized gloves and foot caps in order to prevent chemotherapy-induced peripheral neuropathy (CIPN).

Group B

No intervention was done before and after chemotherapy with paclitaxels.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pressurized gloves and foot caps

Using pressurized gloves and foot caps in order to prevent chemotherapy-induced peripheral neuropathy (CIPN).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Chen Chunyan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunyan Chen

Role: CONTACT

13826423812 ext. 86

Yani Zhang

Role: CONTACT

15914271501 ext. 86

Facility Contacts

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Chunyan Chen, MD

Role: primary

13826423812 ext. 86

Other Identifiers

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B2022-306-01

Identifier Type: -

Identifier Source: org_study_id

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