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

NCT04296929 | Unknown DMC

• 1 other identifier: EBaran
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema; Lymphedema of Upper Arm; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  Change from Baseline touching sensation at 3 weeks

• 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.

  Change from baseline two-point discrimination at 3 weeks

• 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.

  Change from baseline pressure pain threshold at 3 weeks

Secondary Outcomes (5)

• Vibration sensation

  Change from baseline vibration sensation at 3 weeks

• Ultrasonographic Imaging

  Change from baseline ultrasonographic imaging at 3 weeks.

• Environmental measurement

  Change from baseline environmental measurement at 3 weeks.

• Hot / Cold Sensory Test

  Change from baseline Hot/Cold sensory Test at 3 weeks

• Lymphedema Life Impact Scale

  Change from baseline Lymphedema Life Impact Scale at 3 weeks.

Study Arms (2)

Affected arm in lymphedema patients

EXPERIMENTAL

Complex decongestive physiotherapy treatment will be applied to the arm (affected arm) that develops lymphedema after unilateral breast cancer treatment.

Other: Complex Decongestive Physiotherapy

Unaffected arm in lymphedema patients

NO INTERVENTION

After 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.

Interventions

Complex Decongestive Physiotherapy OTHER

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.

Affected arm in lymphedema patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: The study was planned in women with breast cancer related lymphedema.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of lymphedema disease
• Ages between 18-80 years old,
• 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.

You may not qualify if:

• Women with active infection,
• deep vein thrombosis/thrombophlebitis,
• cardiac edema,
• peripheral artery disease,
• kidney, lung disease,
• primary lymphedema,
• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (18)

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• 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.

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• 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.

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• Weiss J, Daniel T. VALIDATION OF THE LYMPHEDEMA LIFE IMPACT SCALE (LLIS): A CONDITION-SPECIFIC MEASUREMENT TOOL FOR PERSONS WITH LYMPHEDEMA. Lymphology. 2015 Sep;48(3):128-38.

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• Orhan C, Uzelpasaci E, Baran E, Nakip G, Ozgul S, Aksoy S, Akbayrak T. The Reliability and Validity of the Turkish Version of the Lymphedema Life Impact Scale in Patients With Breast Cancer-Related Lymphedema. Cancer Nurs. 2020 Sep/Oct;43(5):375-383. doi: 10.1097/NCC.0000000000000709.

  PMID: 30921030 BACKGROUND

• Baran E, Ozcakar L, Ozgul S, Aksoy S, Akbayrak T. Upper limb sensory evaluations and ultrasonographic skin measurements in breast cancer-related lymphedema receiving complex decongestive physiotherapy. Support Care Cancer. 2021 Nov;29(11):6545-6553. doi: 10.1007/s00520-021-06235-4. Epub 2021 Apr 29.

  PMID: 33913006 DERIVED

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Türkan Akbayrak, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Baran, PT, MSc

CONTACT

+903123052525; eminekbaran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Physical Therapist, Master of Science

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: November 28, 2019
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

TU (1)