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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04843410
Recruitment Status : Active, not recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Information provided by (Responsible Party):
Necmiye Comlekci, Istanbul University-Cerrahpasa

Brief Summary:
Chemotherapy-associated peripheral neuropathy is a common complication in patients receiving taxane and platinum-based chemotherapy. Peripheral neuropathy may cause the patient's daily life activities to be hindered, quality of life deteriorated, treatment dose reduced, or even discontinuation of treatment. In the literature, different studies have been carried out using many pharmacological and non-pharmacological approaches in the management of this problem, but so far, any approach that has been shown to be effective in its management has not been clearly defined. One of the approaches whose effectiveness is evaluated in management is exercise. There have been published case reports and several experimental studies examining small patient groups on this subject, and it has been shown to have significant benefits in the management of peripheral neuropathy. This study was planned to determine whether exercise is an effective method in the management of chemotherapy-associated peripheral neuropathy in oncology patients.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Chemotherapeutic Toxicity Other: Hand-foot exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Participant)
Primary Purpose: Supportive Care
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who received at least 3 cycles of taxane and platinum-based treatment (monotherapy or combined) and developed grade 2 or higher peripheral neuropathy as a result of motor and sensory neuropathy evaluation (lung cancer, breast cancer, gynecological cancers, colorectal cancers), Patients with stable vital signs who can tolerate exercise,
  • No bone metastases,
  • Patients older than 18 years old,
  • Patients who agree to participate in the study will participate.

Exclusion Criteria:

  • Newly starting chemotherapy, Peripheral neuropathy due to problems other than chemotherapy (tumor compression, nutritional disorders, infections and systemic diseases such as diabetes mellitus), Vital signs that cannot tolerate exercise are non-stable, Bone metastases,
  • Patients with impaired skin integrity in their hands and feet and who do not agree to participate in the study will not be included in the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04843410

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Istanbul University-Cerrahpasa
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University-Cerrahpasa
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Responsible Party: Necmiye Comlekci, PHD student, Istanbul University-Cerrahpasa Identifier: NCT04843410    
Other Study ID Numbers: 13022260-300-180785
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Necmiye Comlekci, Istanbul University-Cerrahpasa:
peripheral neuropathy, chemotherapy, exercise, oncology
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases