Exercises for Patients Who Were Receiving Chemotherapy

January 8, 2019 updated by: Yeliz Bahar Ozdemir, Hitit University

The Effect of Therapeutic Exercises on Balance, Quality of Life and Pain in Patients Who Were Receiving Neurotoxic Chemotherapy

To evaluate the effect of lower extremity strengthening and balance exercises on balance, quality of life and neuropathic pain of the cancer patients receiving neurotoxic chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cancer-related mortality rates decreased considerably thanks to novel treatment methods and new agents over the last two decades. Although chemotherapy (CT) is an effective treatment type in reducing the size of the tumor and eliminating metastases, it may harm many different organs and systems due to short & long-term side effects. Peripheral neuropathy (PN) is regarded as a neurological and clinical side effect for cancer patients. PN may arise as a paraneoplastic symptom but more commonly occurs with neurotoxic CT agents. Short & long-term side effects that may damage sensory, motor, and autonomic neurons. This damage to the small-fiber sensory nerves causes a change in the sense of touch, pain, and warmth, while the damage to the large-fiber nerves causes a change in the sense of vibration and proprioception. Motor nerve damage affects voluntary movement, muscle tone, and coordination, and damage to the autonomic nervous system affects intestinal motility and blood pressure over smooth muscles. Despite the fact that studies on PN treatment have generally focused on pharmacological agents reducing pain or treating selected side effects, no agent that may be preventive for chemotherapy induced Peripheral Neuropathy (CIPN) due to neurotoxic chemotherapy has been recommended in the review of the American Society of Clinical Oncology.

Side effects due to CT such as anorexia, nausea, vomiting, mucositis, diarrhea, anemia or PN may lead to impairment in the quality of life of the patient and may significantly reduce the level of physical activity. Neurotoxic and ototoxic effects may cause ataxia, paresthesia and dysesthesia, leading to gait, and balance disorders. CIPN has been associated with balance disorder, loss of function and reduced quality of life in the literature. It may result in loss of balance, difficulty in ambulation, increase in the frequency of collapse and accordingly increase in injuries. Despite the fact that medical treatments used in CIPN are often helpful in the treatment of neuropathic pain, no effect has been observed on muscle strength, gait, and balance. It is believed that muscle strength and balance exercises, such as aerobic exercises, can provide mitochondria with oxygen and glucose by increasing blood supply, thereby contributing to energy production and reducing symptoms. Current data suggest that exercise is applicable, safe, and beneficial for this group of patients. Balance exercises at an early stage may prevent or delay the onset of sensory and motor symptoms. Although exercise is accepted as a supportive treatment, which should be addressed more seriously for a patient population with PN, there is not enough information in the literature on timing, frequency, and mode of administration of the treatment program that will be carried out in this specific group of patients.

The aim of this study is to investigate the effects of therapeutic exercise program including concurrently initiated strengthening, balance and aerobic exercises on the symptoms, balance status and quality of life of the group of patients who have a limited physical activity, a risk of developing PN following the treatment, and will have a long-term bed rest and compare with the group of patients not receiving any exercise program in the same treatment period.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Marmara University Pendik Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the ability to understand the informed consent form, and the signing the informed consent form after being informed in detail,
  • planned to have ≥3 cycles of neurotoxic chemotherapy (paclitaxel, docetaxel from taxane class agents, and cisplatin, oxaliplatin or carboplatin from platin group),
  • expected to have a survival of ≥6 months,
  • to have an Eastern Cooperative Oncology Group performance level between 0-2,
  • to have a full manual muscle strength.

Exclusion Criteria:

  • Previously diagnosed peripheral neuropathy (Diabetic peripheral neuropathy, entrapment neuropathies etc.)
  • Patients receiving medical treatment due to neuropathic pain (pregabalin, gabapentin, duloxetine etc.)
  • Pre-existing neurological disease
  • Pre-existing diabetes mellitus (>3 years or insulin use)
  • Alcoholism
  • HIV infection
  • Presence of peripheral vascular disease
  • Vitamin D or vitamin B12 deficiency
  • Non-ambulatory or refuse to practice exercise program
  • Visual or vestibular system impairment
  • Patients with central nervous system involvement or metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise group
Eligible patients who were planned to receive neurotoxic chemotherapy
Other: Exercise
Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient.
No Intervention: Control group
Patients eligible for the study and received the 3rd cycle of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance assessment
Time Frame: 3 months
NeuroCom Balance Master® device (Natus Medical, San Carlos, California, USA) is a balance evaluation device measuring the position of the center of gravity, postural control along with static and dynamic stability.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg balance scale
Time Frame: 3 months
Berg balance scale used in the evaluation of balance based on performance is a 14-item measure in which patient is required to perform different activities.14 different activities are scored between 0 (worst) and 4 (best) according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of patient is good.
3 months
PainDETECT: questionnaire
Time Frame: 3 months
The presence of neuropathic pain was evaluated with the painDETECT questionnaire. The maximum score is 35 and a high score indicates the severity of neuropathic pain. When the PD-Q score is more than 13, it is indicated the presence of neuropathic pain component.
3 months
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Time Frame: 3 months
It is a questionnaire developed by the European Organization for Research and Treatment of Cancer and used to assess the quality of life of cancer patients participating in clinical trials and includes a variety of components. Patients' higher points of functional scale and general health status scale and lower points of symptom scale scores indicate a high QoL.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2015.278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy-induced Peripheral Neuropathy

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe