Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema

NCT05660590 | Completed

• 1 other identifier: BAIBU-FTR-ED-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema The main questions it aims to answer are:

• Is high or low bandage pressure effective in reducing edema and soft tissue thickness?
• do bandages applied with high or low bandage pressure comprimise sleep, comfort or subjective benefit from treatment? Participants will recieve complex decongestive physiotherapy. Bandage will apply high or low pressure. Effects of high and low bandage interface pressures will compare

Conditions

Lymphedema of Upper Limb; Breast Cancer Lymphedema; Edema Arm

Keywords

compelex decongestive physiotherapy; bandage interface pressure; compression therapy

Outcome Measures

Primary Outcomes (2)

• change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up

  Evaluation of skin and subcutaneous tissue thickness and US evaluations were made by a radiologist using a 6-15 MHz linear probe with a LOGIQ US system. Skin and subcutaneous thickness were recorded as milimeter.

  baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)

• change from baseline residual volume with 4 weeks treatment and follow up

  Limb volume was determined by the overflowing water method. The volumetric vessel was filled with tap water up to the overflow point of the vessel. Subjects were asked to lean forward while standing and slowly dip their arms into the water until the bar at the base of the volumetric cup snapped between the 2nd and 3rd fingers. During immersion, he was asked to avoid movements that could increase the transport of water. The overflowing water was first taken into a container. Then, the overflow water was calculated by transferring it to the measuring cups. The amount of overflowing water was recorded in ml. Measurements were made bilaterally.

  baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)

Secondary Outcomes (3)

• sleep quality

  baseline, 4 weeks, 3 months (follow-up)

• Comfort

  baseline, 4 weeks, 3 months (follow-up)

• Subjective benefit from treatment

  4 weeks

Study Arms (2)

Low bandage pressure

ACTIVE COMPARATOR

Compression bandages applied with low pressure (20-30 mmHg)

Other: complex decongestive physiotherapy with low pressure compression bandage

high bandage pressure

ACTIVE COMPARATOR

Compression bandages applied with low pressure (45-55 mmHg)

Other: complex decongestive physiotherapy with high pressure compression bandage

Interventions

complex decongestive physiotherapy with low pressure compression bandage OTHER

both group received complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with low bandage interface pressure (20-30 mmHg)

Also known as: Low bandage interface pressure

Low bandage pressure

complex decongestive physiotherapy with high pressure compression bandage OTHER

complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with high bandage interface pressure (45-55 mmHg)

Also known as: High bandage interface pressure

high bandage pressure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 2 unilateral BCRL involving whole extremity according to ISL
• To be volunteer.

You may not qualify if:

• Acute deep vein thrombosis
• Acute soft tissue infection
• Peripheral artery disease in upper extremity
• Systemic diseases with peripheral edema (kidney, hearth insufficiency etc.),
• Allergy to materials used for treatment
• Mental diseases effect cooperation
• Sensory loss in the effected limb
• Open wound in the effected limb.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abany Izzet Baysal University

Bolu, Center, 14030, Turkey (Türkiye)

Location

Related Publications (1)

• Duygu-Yildiz E, Bakar Y, Hizal M. The effect of complex decongestive physiotherapy applied with different compression pressures on skin and subcutaneous tissue thickness in individuals with breast cancer-related lymphedema: a double-blinded randomized comparison trial. Support Care Cancer. 2023 Jun 7;31(7):383. doi: 10.1007/s00520-023-07843-y.

  PMID: 37285046 DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• elif duygu yıldız, Dr

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: radiologist who assessed soft tissue thickness assessment is masked and the patients did't know which group they belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Randomised comparison trial

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 21, 2022
• Study Start: June 1, 2019
• Primary Completion: April 22, 2022
• Study Completion: May 18, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)