Clinical trial NCT05610579: The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema
Official title: The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema, Breast Cancer
Keywords: compression therapy
lymphedema
exercise
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study to investigate 24 hours of effects of remedial exercises with and without compression therapy on severity of lymphedema and symptoms of the lymphedema The present study is designed as a non-drug clinical trial. The patients will complete two remedial exercise sessions, one without and one with compression in a randomized order separated by a 3-day wash-out period.The main questions it aims to answer are

1. The 24 hour effects of remedial exercises with and without compression therapy on the severity of lymphedema are different in individuals with lymphedema associated with breast cancer surgery.
2. The 24 hour effects of remedial exercises with and without compression therapy on the symptoms of lymphedema are different in individuals with lymphedema associated with breast cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of unilateral arm lymphedema related to breast cancer disease- Age between 18 and 75 years
* 2 cm or greater difference between the affected and unaffected arms in women with breast cancer related lymphedema
* At least 12 months after breast cancer surgery end

Exclusion Criteria:

* current recurrence of breast cancer
* bilateral involvement
* active infection
* presence of metastases
* diabetes mellitus
* hypertension
* pre-existing neuromusculoskeletal and neurological conditions
* edema due to other reasons (e.g., primary lymphedema, lung and heart diseases)

Primary outcomes:
measure: Ultrasonographic measurements
timeFrame: Change in symptoms related to lymphedema from baseline up to end of 24 hour
measure: Circumference measurement
timeFrame: Change in symptoms related to lymphedema from baseline up to end of 24 hour
measure: Bioimpedance spectroscopy
timeFrame: Change in symptoms related to lymphedema from baseline up to end of 24 hour
Secondary outcomes:
measure: symptoms of lymphedema
timeFrame: Change in symptoms related to lymphedema from baseline up to end of 24 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gülbala Nakip
Study officials:
References:
citation: McNeely ML, Campbell K, Ospina M, Rowe BH, Dabbs K, Klassen TP, Mackey J, Courneya K. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD005211. doi: 10.1002/14651858.CD005211.pub2.
citation: McNeely ML, Campbell KL, Courneya KS, Mackey JR. Effect of acute exercise on upper-limb volume in breast cancer survivors: a pilot study. Physiother Can. 2009 Fall;61(4):244-51. doi: 10.3138/physio.61.4.244. Epub 2009 Nov 12.
citation: Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH, Soballe P. Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer. 2008 Jun 15;112(12):2809-19. doi: 10.1002/cncr.23494.
citation: De Vrieze T, Vos L, Gebruers N, Tjalma WAA, Thomis S, Neven P, Nevelsteen I, De Groef A, Vandermeeren L, Belgrado JP, Devoogdt N. Protocol of a randomised controlled trial regarding the effectiveness of fluoroscopy-guided manual lymph drainage for the treatment of breast cancer-related lymphoedema (EFforT-BCRL trial). Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:177-188. doi: 10.1016/j.ejogrb.2017.12.023. Epub 2017 Dec 16.
citation: Svensson BJ, Dylke ES, Ward LC, Black DA, Kilbreath SL. Screening for breast cancer-related lymphoedema: self-assessment of symptoms and signs. Support Care Cancer. 2020 Jul;28(7):3073-3080. doi: 10.1007/s00520-019-05083-7. Epub 2019 Oct 22.
citation: Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
citation: Ricci V, Ricci C, Gervasoni F, Andreoli A, Ozcakar L. From histo-anatomy to sonography in lymphedema: EURO-MUSCULUS/USPRM approach. Eur J Phys Rehabil Med. 2022 Feb;58(1):108-117. doi: 10.23736/S1973-9087.21.06853-2. Epub 2021 Apr 16.