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LymphedemaNCT04296929

The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.

A study testing Complex Decongestive Physiotherapy in people with Lymphedema and Lymphedema of Upper Arm, run by Hacettepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to determine the effect of complex decongestive physiotherapy in women with unilateral breast cancer-related lymphedema on sensory parameters. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Lymphedema, Lymphedema of Upper Arm, Breast Cancer
What is being tested?
Complex Decongestive Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Nov 2019to 1 Dec 2021
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 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of lymphedema disease
  • Ages between 18-80 years old,
  • 2 cm difference between the affected and unaffected arms in women with breast cancer related lymphedema,
  • At least 12 months after breast cancer treatments end and
  • Who are agreed to participate in the study.

Who cannot join

  • Women with active infection,
  • deep vein thrombosis/thrombophlebitis,
  • cardiac edema,
  • peripheral artery disease,
  • kidney, lung disease,
  • primary lymphedema,
Show all 13Show fewer
  • peripheral upper limb nerve injury,
  • any surgery other than breast cancer surgeries,
  • existing shoulder, elbow, wrist, hand pathologies,
  • cooperation problems,
  • neurological disease,
  • mental illness, diabetes mellitus,
  • smoking and patients with open wounds on the upper limb.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Hacettepe University

    Ankara, Samanpazari, 06100

    Türkan Akbayrak, Prof, +903123052525 ext. 170, takbayrak@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema Patients

The aim of this study was to determine the effect of complex decongestive physiotherapy in women with unilateral breast cancer-related lymphedema on sensory parameters.

Read the detailed description

Although there are a limited number of studies in the literature on disorders of sensory functions seen after breast cancer treatments, sensory disorders that may be seen in lymphedema associated with breast cancer were evaluated in only 2 studies published in 1979 and 2006. Although these studies are not sufficient in terms of study design, they only include Semmes-Weinstein monofilaments and two-point discrimination tests and hand evaluations. Ganel et al. Reported that approximately 50% of the patients they included in the study found that varying degrees of lymphedema developed in the upper extremity, and the median nerve compression in the brachial plexus and carpal tunnel was significantly higher in these patients. They did not find a direct correlation with radiotherapy in patients with nerve compression. They therefore stated that nerve compression may be associated with lymphedema or fibroblast infiltration. According to this study, lymphedema may also be a risk factor in post mastectomy problems such as brachial plexus and carpal tunnel syndrome. Greve et al. reported that lymphedema may cause a decrease in sensory functions in patients who were evaluated with monofilaments in their studies on the effect of lymphedema on sensory functions after mastectomy (Ganel 1979, Greeve 2006).

Complex Decongestive Physiotherapy was developed by Földi in the 1980s in Germany to reduce limb volume, preserve skin health, lymph transport stimulation and reabsorption of residual interstitial proteins. Complex Decongestive Physiotherapy is a treatment method consisting of four main elements and two phases. The four main elements of the first phase of complex decongestive physiotherapy; includes manual lymphatic drainage, skin care, compression therapy and remedial exercises. After the edema is reduced, phase II is passed. This phase includes self-drainage, skin care, personalized compression socks and remedial exercises. In lymphedema, protein-rich fluid accumulates in the subcutaneous tissue for a long time, disrupting natural skin elasticity over time. With Complex Decongestive Physiotherapy, edema reduction up to 65% can be achieved, functional loss, fibrotic changes, and cosmetic problems, which are the secondary problems caused by lymphedema, can be observed.

Increased interstitial fluid in lymphedema associated with breast cancer can cause local sensory loss due to compression of peripheral nerves. Dermal thickness increase due to lymphedema and biomechanical changes in viscoelasticity can cause various changes on sensory functions. Therefore, quantitative evaluation of the sensory system can be an effective method to determine the injury risk factor of the lymphedema region in the event of an existing sensory dysfunction. However, although the effects of Complex Decongestive Physiotherapy on edema reduction, skin thickness and elasticity are mentioned, its effect on sensory functions is unknown.

Complex Decongestive Physiotherapy will be applied to patients for a total of 3 weeks, 5 days a week within the scope of this study.

The assessments will be performed before treatment and at the end of three weeks treatment period.

A detailed story will be taken from the patients first. The lymphedema diagnoses of the patients will be confirmed by ultrasonographic imaging method. Imaging will be performed using a 5-12 MHz linear probe (Logiq P5, GE, Wisconsin, USA) on the upper extremity. Dermis and subcutaneous soft tissue thicknesses; It will be measured using plenty of gel, using images without applying any pressure - with the help of the device's automatic calculation feature after marking.

The severity of lymphedema between the two extremities will be assessed by environmental measurement.

Semmes-Weinstein Monofilament Test: It will be applied 10 cm distal to the elbow joint of the volar surface in the forearm. The measurement will start with the lightest monofilament and proceed to the monofilament that the patient feels. Each monofilament will be applied to a spot three times in a row.

Two Point Discrimination Test: This test is a non-invasive test commonly used in sensory evaluation. It is done by randomly touching one or two points. If 7 of the 10 answers given by the patient are correct, the answer is considered correct. If the answer is not correct, the difference between the two ends of the esthesiometer is increased by 1, 2 or 5 mm depending on the expected state of sensory loss. The test continues until you reach the correct answer. If the correct answer cannot be obtained even at 15 mm, the test is terminated.

The pressure pain threshold will be evaluated with 'J tech Algometer Commander' by giving pressure from both the upper extremity to 10 cm distal from the volar surface of the elbow joint until the patient feels minimal pain. Pressure will be applied vertically with the 1 cm2 head of the device and patients will be asked to say 'yes' whenever they feel uncomfortable with the pressure applied. The measurement will be repeated 3 times, and the pressure pain threshold will be calculated by taking the arithmetic average of these three trials.

Hot / Cold Sensory Test: The sense of warm / cold will be evaluated with test tubes containing hot and cold liquid. The cold tube will be filled with water at 10 °C and the hot tube at 40 °C. When the patient's eyes are closed, these tubes will be touched to the skin surface 10 cm distal to the volar face elbow joint in a random order, and the patient will be asked to express that the water in the tube is hot or cold.

Vibration Sensation Measurement: The vibration sensation will be measured from the lateral epicondyle in the upper extremity by diapason. Diapason is a small U-shaped tool made of steel that vibrates at a certain height when vibrated.

Lymphedema Life Impact Scale: Weiss et al. The validity and reliability of the questionnaire developed by Orhan et al. made by. Lymphedema life impact scale consists of 18 questions and has physical, psychological and functional subtitles. '0'; no influence, '4'; It is scored between the minimum '0' and the maximum '72' score with a 5-stage Likert-type scale in the form of severe influence. As the score increases, the state of influence worsens.

Being tested
Complex Decongestive Physiotherapy
Medical subject headings
Lymphedema, Breast Neoplasms

What participants receive

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

  • Complex Decongestive PhysiotherapyOther

    Complete decongestive therapy (CDT), also called complex decongestive therapy, is an intensive program that combines many of the different treatment approaches, including bandaging, compression garments, manual lymphatic drainage, exercise, and self care.

Study groups in NCT04296929
Study groupRoleWhat they receive
Affected arm in lymphedema patientsExperimentalComplex decongestive physiotherapy treatment will be applied to the arm (affected arm) that develops lymphedema after unilateral breast cancer treatment.
Receives: Other: Complex Decongestive Physiotherapy
Unaffected arm in lymphedema patientsNo interventionAfter unilateral breast cancer treatments, the non-lymphedema side in the upper extremities, is the unaffected arm. No treatments will be applied to the unaffected side.

What is being measured

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

  1. Touching sensation

    Assessment of touching sensation at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with Semmes-Weinstein Monofilaments in women with breast cancer related lymphedema.

    Measured: Change from Baseline touching sensation at 3 weeks

  2. Two-point discrimination

    Assessment of two-point discrimination at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an esthesiometer in women with breast cancer related lymphedema.

    Measured: Change from baseline two-point discrimination at 3 weeks

  3. Pressure pain threshold

    Assessment of pressure pain threshold at 10 cm distal to the elbow on the volar surface in affected and unaffected arms at least 12 months after the breast cancer treatment, with an algometer in women with breast cancer related lymphedema.

    Measured: Change from baseline pressure pain threshold at 3 weeks

Secondary outcomes (5)
  1. Vibration sensation

    Vibration Sensation Measurement: The vibration sensation will be measured from the lateral epicondyle in the upper extremity by diapasons. Diapason is a small U-shaped tool made of steel that vibrates at a certain height when vibrated. 128 and 256 Hertz diapasons will be vibrated and placed in the patient's lateral epicondyle. The time that the patient feels vibration will be calculated with a chronometer.

    Measured: Change from baseline vibration sensation at 3 weeks

  2. Ultrasonographic Imaging

    The lymphedema diagnoses of the patients will be confirmed by ultrasonographic imaging method routinely performed in the clinic. Imaging will be performed using a 5-12 MHz linear probe (Logiq P5, GE, Wisconsin, USA) on the upper extremity. Dermis and subcutaneous soft tissue thicknesses; It will be measured using plenty of gel, using images without applying any pressure - with the help of the device's automatic calculation feature after marking.

    Measured: Change from baseline ultrasonographic imaging at 3 weeks.

  3. Environmental measurement

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

    Measured: Change from baseline environmental measurement at 3 weeks.

  4. Hot / Cold Sensory Test

    The sense of warm / cold will be evaluated with test tubes containing hot and cold liquid. The cold tube will be filled with water at 10 ° C and the hot tube at 40 ° C. When the patient's eyes are closed, these tubes will be touched to the skin surface 10 cm distal to the volar face elbow joint in a random order, and the patient will be asked to express that the water in the tube is hot or cold.

    Measured: Change from baseline Hot/Cold sensory Test at 3 weeks

  5. Lymphedema Life Impact Scale

    Lymphedema Life Impact Scale: Weiss et al. The validity and reliability of the questionnaire developed by Orhan et al. made by. Lymphedema life impact scale consists of 18 questions and has physical, psychological and functional subtitles. '0'; no influence, '4'; It is scored between the minimum '0' and the maximum '72' score with a 5-stage Likert-type scale in the form of severe influence. As the score increases, the state of influence worsens.

    Measured: Change from baseline Lymphedema Life Impact Scale at 3 weeks.

Timeline

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

  1. First posted5 Mar 2020
  2. Study start28 Nov 2019
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296929
Sponsor's protocol ID
EBaran
Status last verified
Mar 2020
First submitted
2 Mar 2020
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

    PubMed 25220842
  • Ribeiro Pereira ACP, Koifman RJ, Bergmann A. Incidence and risk factors of lymphedema after breast cancer treatment: 10 years of follow-up. Breast. 2017 Dec;36:67-73. doi: 10.1016/j.breast.2017.09.006. Epub 2017 Oct 6.

    PubMed 28992556
  • Rijke AM, Croft BY, Johnson RA, de Jongste AB, Camps JA. Lymphoscintigraphy and lymphedema of the lower extremities. J Nucl Med. 1990 Jun;31(6):990-8.

    PubMed 2348245
  • Goyal A, Newcombe RG, Chhabra A, Mansel RE. Morbidity in breast cancer patients with sentinel node metastases undergoing delayed axillary lymph node dissection (ALND) compared with immediate ALND. Ann Surg Oncol. 2008 Jan;15(1):262-7. doi: 10.1245/s10434-007-9593-3. Epub 2007 Sep 19.

    PubMed 17879117
  • Wu SG, Huang SJ, Zhou J, Sun JY, Guo H, Li FY, Lin Q, Lin HX, He ZY. Dosimetric analysis of the brachial plexus among patients with breast cancer treated with post-mastectomy radiotherapy to the ipsilateral supraclavicular area: report of 3 cases of radiation-induced brachial plexus neuropathy. Radiat Oncol. 2014 Dec 12;9:292. doi: 10.1186/s13014-014-0292-5.

    PubMed 25499205
  • Warmuth MA, Bowen G, Prosnitz LR, Chu L, Broadwater G, Peterson B, Leight G, Winer EP. Complications of axillary lymph node dissection for carcinoma of the breast: a report based on a patient survey. Cancer. 1998 Oct 1;83(7):1362-8. doi: 10.1002/(sici)1097-0142(19981001)83:73.0.co;2-2.

    PubMed 9762937
  • Andersen KG, Duriaud HM, Kehlet H, Aasvang EK. The Relationship Between Sensory Loss and Persistent Pain 1 Year After Breast Cancer Surgery. J Pain. 2017 Sep;18(9):1129-1138. doi: 10.1016/j.jpain.2017.05.002. Epub 2017 May 11.

    PubMed 28502878
  • Say CC, Donegan W. A biostatistical evaluation of complications from mastectomy. Surg Gynecol Obstet. 1974 Mar;138(3):370-6. No abstract available.

    PubMed 4811322
  • Ganel A, Engel J, Sela M, Brooks M. Nerve entrapments associated with postmastectomy lymphedema. Cancer. 1979 Dec;44(6):2254-9. doi: 10.1002/1097-0142(197912)44:63.0.co;2-9.

    PubMed 509395
  • Foldi M, Foldi E. [Therapy of lymphedema]. Med Welt. 1980 May 23;31(21):801-6. No abstract available. German.

    PubMed 6993841
  • Lim CY, Seo HG, Kim K, Chung SG, Seo KS. Measurement of lymphedema using ultrasonography with the compression method. Lymphology. 2011 Jun;44(2):72-81.

    PubMed 21949976
  • Voerman VF, van Egmond J, Crul BJ. Normal values for sensory thresholds in the cervical dermatomes: a critical note on the use of Semmes-Weinstein monofilaments. Am J Phys Med Rehabil. 1999 Jan-Feb;78(1):24-9. doi: 10.1097/00002060-199901000-00007.

    PubMed 9923425
  • MOBERG E. Objective methods for determining the functional value of sensibility in the hand. J Bone Joint Surg Br. 1958 Aug;40-B(3):454-76. doi: 10.1302/0301-620X.40B3.454. No abstract available.

    PubMed 13575459
  • Dellon AL. The moving two-point discrimination test: clinical evaluation of the quickly adapting fiber/receptor system. J Hand Surg Am. 1978 Sep;3(5):474-81. doi: 10.1016/s0363-5023(78)80143-9.

    PubMed 568154
  • Granges G, Littlejohn G. Pressure pain threshold in pain-free subjects, in patients with chronic regional pain syndromes, and in patients with fibromyalgia syndrome. Arthritis Rheum. 1993 May;36(5):642-6. doi: 10.1002/art.1780360510.

    PubMed 8489541

Questions about this trial

What is this clinical trial studying?

A study testing Complex Decongestive Physiotherapy in people with Lymphedema and Lymphedema of Upper Arm, 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 5 Mar 2020. 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?

Results are not available in the source record.

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

Contact Emine Baran, PT, MSc (+903123052525 ext. 173, eminekbaran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Touching sensation (time frame: Change from Baseline touching sensation at 3 weeks). 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 NCT04296929, which also lists 18 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 5 Mar 2020.

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