EFFECT OF EXERCISE IN THE MANAGEMENT OF CHEMOTHERAPY-RELATED PERIPHERAL NEUROPATHY
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|ClinicalTrials.gov Identifier: NCT04843410|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Peripheral Neuropathy Chemotherapeutic Toxicity||Other: Hand-foot exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|Primary Purpose:||Supportive Care|
|Official Title:||EFFECT OF EXERCISE IN THE MANAGEMENT OF CHEMOTHERAPY-RELATED PERIPHERAL NEUROPATHY|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||January 2022|
|Experimental: Experimental: exercise group||
Other: Hand-foot exercise
The experimental group will be taught a regular exercise program for 15 minutes twice a day. The sensory exercise ball required for exercise will be given to the patients by the researcher. In addition, visual training material will be provided for the exercise program so that the patient can repeat the training at any time to ensure the permanence of the patient education. The standard care protocol of the clinic will be applied to the control group.
|No Intervention: No Intervention: Control Group|
- Patient Information Form [ Time Frame: Baseline (first meeting (start the study)) ]Patient Information Form: The patient information form developed by the researcher in line with the literature will be used in collecting data. The patient information form consists of 5 sections: personal characteristics, economic status, information about the health process, information about peripheral neuropathy and information about the disease process.
- Common Terminology Criteria for Adverse Events (CTCAE) - Version 5.0 Classification [ Time Frame: 8 weeks ]Common Terminology Criteria for Adverse Events (CTCAE) - Version 5.0 Classification: The CTCAE 5.0 classification was designed by the American National Cancer Institute (NCI) to broadly describe and rank adverse reactions that may arise from a variety of causes. A rating (severity) scale is given for each side effect term. In this classification, grad indicates the severity of the side effect. The severity of adverse events were graded: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life threatening), and grade 5 (side effect-related death).
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: 8 weeks ]The overall quality of life of patients will be assessed using the European Organization for Cancer Research and Treatment Quality of Life Scale. The scale was developed by EORTC, content validity and reliability study was performed by Beşer and Öz in our country, and the Cronbach alpha reliability coefficient was found to be r = 0.9014. The EORTC QLQC30 Version 3.0 quality of life scale is a widely used quality of life assessment tool for patients with cancer. The EORTC-QLQ-C30 consists of 30 questions and three subtitles: general well-being, functional difficulties and symptom control.
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) [ Time Frame: 8 weeks ]The EORTC QLQ-CIPN20 is a 20-item assessment tool used to reveal the symptoms of peripheral neuropathy associated with chemotherapy and the effect of functional limitations caused by this problem on patients' lives. Scale to be sensory (tingling, numbness, pain, instability while walking or standing, discriminating temperature and hearing), motor (cramps, writing, grasping small objects, weakness) and autonomic (dizziness after changing position, vision, erectile dysfunction) It has 3 subscales. The 20 items in the scale are Likert-type and the answers are evaluated by giving None "1", a little "2", Rather "3", and a lot of "4" points. High scores from these sections indicate more symptoms and problems, and low scores indicate less symptoms and problems.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843410