Clinical trial NCT03798379: Exercises for Patients Who Were Receiving Chemotherapy
Official title: The Effect of Therapeutic Exercises on Balance, Quality of Life and Pain in Patients Who Were Receiving Neurotoxic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: cancer
chemotherapy
peripheral neuropathy
exercise
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Balance assessment
timeFrame: 3 months
Secondary outcomes:
measure: Berg balance scale
timeFrame: 3 months
measure: PainDETECT: questionnaire
timeFrame: 3 months
measure: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
Study officials:
References:
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citation: Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568.
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citation: Cammisuli S, Cavazzi E, Baldissarro E, Leandri M. Rehabilitation of balance disturbances due to chemotherapy-induced peripheral neuropathy: a pilot study. Eur J Phys Rehabil Med. 2016 Aug;52(4):479-88. Epub 2016 May 31.
citation: Nurgalieva Z, Xia R, Liu CC, Burau K, Hardy D, Du XL. Risk of chemotherapy-induced peripheral neuropathy in large population-based cohorts of elderly patients with breast, ovarian, and lung cancer. Am J Ther. 2010 Mar-Apr;17(2):148-58. doi: 10.1097/MJT.0b013e3181a3e50b.
citation: Hershman DL, Lacchetti C, Loprinzi CL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2014 Nov;10(6):e421-e424. doi: 10.1200/JOP.2014.001776. No abstract available.