Exercises for Patients Who Were Receiving Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Non randomized, single blind, prospective

Study Groups

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Exercise group

Eligible patients who were planned to receive neurotoxic chemotherapy

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient.

Control group

Patients eligible for the study and received the 3rd cycle of chemotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No