Exercises for Patients Who Were Receiving Chemotherapy

NCT03798379 | Completed

• 1 other identifier: 09.2015.278
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

cancer; chemotherapy; peripheral neuropathy; exercise

Outcome Measures

Primary Outcomes (1)

• Balance assessment

  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 Outcomes (3)

• Berg balance scale

  3 months

• PainDETECT: questionnaire

  3 months

• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

  3 months

Study Arms (2)

Exercise group

ACTIVE COMPARATOR

Eligible patients who were planned to receive neurotoxic chemotherapy

Other: Exercise

Control group

NO INTERVENTION

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

Interventions

Exercise OTHER

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

Exercise group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (6)

• Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.

  PMID: 28963591 BACKGROUND

• 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.

  PMID: 24478323 BACKGROUND

• Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

  PMID: 25261162 BACKGROUND

• 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.

  PMID: 27243828 BACKGROUND

• 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.

  PMID: 19417586 BACKGROUND

• 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.

  PMID: 29424607 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Peripheral Nervous System Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Non randomized, single blind, prospective
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 9, 2019
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

TU (1)