Effect of Exercise in the Management of Peripheral Neuropathy

NCT04843410 | Completed

• 1 other identifier: 13022260-300-180785
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 to deteriorate, 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Chemotherapeutic Toxicity

Keywords

peripheral neuropathy, chemotherapy, exercise, oncology

Outcome Measures

Primary Outcomes (4)

• Patient Information Form

  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.

  Baseline (first meeting (start the study))

• Common Terminology Criteria for Adverse Events (CTCAE) - Version 5.0 Classification

  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).

  8 weeks

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  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.

  8 weeks

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20)

  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.

  8 weeks

Study Arms (2)

Experimental: Exercise group

EXPERIMENTAL

In this prospective study, patients who applied to Zonguldak Atatürk State Hospital Oncology Outpatient Clinic received at least three cures of taxane and platinum-based treatment (monotherapy or combined) and developed grade 2 and higher peripheral neuropathy (lung cancer, breast cancer) as a result of motor and sensory neuropathy evaluation. , gynecological cancers, colorectal cancers), patients with stable vital signs who can tolerate the exercise, patients without bone metastases, patients older than 18 years of age, and patients who agree to participate in the study. The experimental group will be taught an exercise program to apply regularly twice a day. The researcher will give the patient the barbed ball and barbed roller required for the exercise. In addition, visual training material will be given for the exercise program so that the patient can repeat the training whenever he wants to ensure the permanence of the patient education.

Other: Hand-foot exercise

The routine care: Control Group

SHAM COMPARATOR

In this prospective study, patients who applied to Zonguldak Atatürk State Hospital Oncology Outpatient Clinic received at least 3 cures of taxane and platinum-based treatment (monotherapy or combined) and developed grade 2 and higher peripheral neuropathy (lung cancer, breast cancer) as a result of motor and sensory neuropathy evaluation. , gynecological cancers, colorectal cancers), patients with stable vital signs, patients without bone metastases, patients older than 18 years of age, and patients who agree to participate in the study. The routine care of the clinic will be applied to the control group.

Other: The routine care

Interventions

Hand-foot exercise OTHER

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.

Experimental: Exercise group

The routine care OTHER

Education about chemotherapy-associated peripheral neuropathy risk factors, why it develops and its management

The routine care: Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Officials

• Necmiye ÇÖMLEKÇİ, MSc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 13, 2021
• Study Start: September 1, 2020
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For 10 years

Locations

TU (1)