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Lymphedema, Breast CancerNCT05610579

The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema

A study testing Remedial exercise and Compression bandage in people with Lymphedema, Breast Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Lymphedema, Breast Cancer
What is being tested?
Remedial exercise and Compression bandage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Nov 2022to 28 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gülbala Nakip

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

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.
Being tested
Remedial exercise, Compression bandage
Keywords
compression therapy, lymphedema, exercise
Medical subject headings
Breast Cancer Lymphedema, Lymphedema, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remedial exerciseOther

    Remedial exercise program will be taught by qualified physiotherapist. Patients will be practiced to the exercise 3 sets of 15 repetitions without compression. Patients will be monitored telephonically in the washout period for remain the routine activities.

  • Compression bandageOther

    Multi-layered short stretch bandaging will be applied for 23 hour. Patients will be practiced to the exercise 3 sets of 15 repetitions with compression bandage. The bandage will be removed at the same time the next day. Patients will be monitored telephonically in the washout period for remain the routine activities.

Study groups in NCT05610579
Study groupRoleWhat they receive
remedial exercises with compression bandageExperimentalNot described
Receives: Other: Remedial exercise; Other: Compression bandage
remedial exercisesActive comparatorNot described
Receives: Other: Remedial exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ultrasonographic measurements

    Ultrasound imaging was performed using a 5-13-Megahertz linear probe. During the procedure, the participants will be seated with their forearms supinated and extended on a pillow. Measurements will be made bilaterally from 10 cm distal and proximal to the elbow bend, from the midpoint of the medial and lateral epicondyles, along the line parallel to the arm axis.

    Measured: Change in symptoms related to lymphedema from baseline up to end of 24 hour

  2. Circumference measurement

    The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.

    Measured: Change in symptoms related to lymphedema from baseline up to end of 24 hour

  3. Bioimpedance spectroscopy

    The patient is in the supine position with his arms and legs not touching each other. This measurement will be made using the Impedimed L-Dex U 400 device. The reference point is the top of both hands and the dorsum of the foot. This measurement is made using superficial electrodes and there is no risk. The percentage of fluid will be calculated by making a measurement for both arms.

    Measured: Change in symptoms related to lymphedema from baseline up to end of 24 hour

Secondary outcomes (1)

  1. symptoms of lymphedema

    Four participant-reported lymphedema symptoms were assessed: swelling, heaviness, tightness commonly associated with BCRL. Using a 100 mm visual analogue scale (VAS), participants marked on it the extent to which they perceived their arm to be swollen, heavy or tight and pain during the past month, with 0 being "not at all" and 10 being "extremely".

    Measured: Change in symptoms related to lymphedema from baseline up to end of 24 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start14 Nov 2022
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610579
Sponsor's protocol ID
KA22053
Status last verified
Jul 2023
First submitted
3 Nov 2022
Last updated
1 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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;2010(6):CD005211. doi: 10.1002/14651858.CD005211.pub2.

    PubMed 20556760

  • 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.

    PubMed 20808486

  • 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.

    PubMed 18428212

  • 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.

    PubMed 29277358

  • 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.

    PubMed 31641870

  • 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.

    PubMed 12861145

  • 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.

    PubMed 33861039

Questions about this trial

What is this clinical trial studying?

A study testing Remedial exercise and Compression bandage in people with Lymphedema, Breast Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasonographic measurements (time frame: Change in symptoms related to lymphedema from baseline up to end of 24 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610579, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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