search
Back to results

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

Primary Purpose

Nasopharyngeal Carcinoma, CIPN - Chemotherapy-Induced Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pressurized gloves and foot caps
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasopharyngeal Carcinoma focused on measuring Paclitaxel, Compression therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

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

No intervention was done before and after chemotherapy with paclitaxels.

Outcomes

Primary Outcome Measures

Evaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)
The incidence of common adverse event evaluation criteria (CTCAE) 5.0 ≥ 2°CIPN after compression therapy with pressurized gloves and foot caps is used to objectively assess the peripheral neurotoxicity of chemotherapy. The grade of CTCAE 5.0 CIPN before treatment was the baseline (=0). We assess changes from baseline at 15 minutes after the end of each cycle, 3 and 6 months after the end of treatment. (The duration of chemotherapy varies according to the type of paclitaxel and the interval of each cycle of chemotherapy is 21 days). CIPN includes the symptoms of a sensory nerve and motor nerve injury. The symptoms are graded from 1 to 5, indicating none, mild, severe, life-threatening, and death. The higher the grade, the worse the neurotoxicity. The most severe grade is the final grade for each patient.

Secondary Outcome Measures

EORTC QLQ-CIPN20 score
The European Organization for Research and Treatment of Cancer Evaluation Scale of Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) is a validated tool to objectively assess the peripheral neurotoxicity of chemotherapy. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. This scale includes the symptoms of sensory nerve, motor nerve, and autonomic nerve injury and its impact on life. A total of 20 items are included. Each item is graded from 1 to 4, indicating none, occasionally, often, and very often. According to the patient's self-reported score, the higher the score, the worse the quality of life.
EORTC QLQ-C30 score
The European Organization for Cancer Research and Treatment QLQ-C30 （EORTC QLQ-C30）: a quality of life instrument for use in international clinical trials in oncology. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
NRS score
The Numerical Rating Scale (NRS) scale is a validated tool to objectively assess the tolerance of participants for gloves and coats, with a minimum score of 0 and a maximum of 10. A score of 0 indicates complete tolerance, a score of 1-3 indicates mild intolerance, a score of 4-6 indicates moderate intolerance, and a score of 7-10 indicates severe intolerance.

Full Information

First Posted
August 27, 2022
Last Updated
April 13, 2023
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT05531916
Brief Title
Compression Therapy as a Prophylactic Method Against CIPN: a Prospective Self-controlled Trial
Acronym
CIPN
Official Title
Compression Therapy as a Prophylactic Method Against Paclitaxel-induced Peripheral Neuropathy: a Prospective Self-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, CIPN - Chemotherapy-Induced Peripheral Neuropathy
Keywords
Paclitaxel, Compression therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants wear pressurized gloves and foot caps for 15 minutes before their chemotherapy treatment, during the treatment, and for 15 minutes after it ended.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
No intervention was done before and after chemotherapy with paclitaxels.
Intervention Type
Other
Intervention Name(s)
Pressurized gloves and foot caps
Intervention Description
Using pressurized gloves and foot caps in order to prevent chemotherapy-induced peripheral neuropathy (CIPN).
Primary Outcome Measure Information:
Title
Evaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)
Description
The incidence of common adverse event evaluation criteria (CTCAE) 5.0 ≥ 2°CIPN after compression therapy with pressurized gloves and foot caps is used to objectively assess the peripheral neurotoxicity of chemotherapy. The grade of CTCAE 5.0 CIPN before treatment was the baseline (=0). We assess changes from baseline at 15 minutes after the end of each cycle, 3 and 6 months after the end of treatment. (The duration of chemotherapy varies according to the type of paclitaxel and the interval of each cycle of chemotherapy is 21 days). CIPN includes the symptoms of a sensory nerve and motor nerve injury. The symptoms are graded from 1 to 5, indicating none, mild, severe, life-threatening, and death. The higher the grade, the worse the neurotoxicity. The most severe grade is the final grade for each patient.
Time Frame
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 Outcome Measure Information:
Title
EORTC QLQ-CIPN20 score
Description
The European Organization for Research and Treatment of Cancer Evaluation Scale of Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) is a validated tool to objectively assess the peripheral neurotoxicity of chemotherapy. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. This scale includes the symptoms of sensory nerve, motor nerve, and autonomic nerve injury and its impact on life. A total of 20 items are included. Each item is graded from 1 to 4, indicating none, occasionally, often, and very often. According to the patient's self-reported score, the higher the score, the worse the quality of life.
Time Frame
Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.
Title
EORTC QLQ-C30 score
Description
The European Organization for Cancer Research and Treatment QLQ-C30 （EORTC QLQ-C30）: a quality of life instrument for use in international clinical trials in oncology. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Time Frame
Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days), 3 and 6 months after chemotherapy completion.
Title
NRS score
Description
The Numerical Rating Scale (NRS) scale is a validated tool to objectively assess the tolerance of participants for gloves and coats, with a minimum score of 0 and a maximum of 10. A score of 0 indicates complete tolerance, a score of 1-3 indicates mild intolerance, a score of 4-6 indicates moderate intolerance, and a score of 7-10 indicates severe intolerance.
Time Frame
Pretreatment（baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunyan Chen
Phone
13826423812
Ext
86
Email
chenchuny@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yani Zhang
Phone
15914271501
Ext
86
Email
zhangyn1@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunyan Chen, MD
Phone
13826423812
Ext
86
Email
chenchuny@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs