Treatment of Breast Cancer-related Lymphoedema

NCT03992508 | Completed

• 1 other identifier: 2012/99
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Change of excess arm volume from baseline

  The volume of every part of the limb was calculated in liter by the truncated cone formula according to circumferential measurements.

  a month

Secondary Outcomes (4)

• Change of arm pain, heaviness and tightness from baseline

  a month

• Change of disability from baseline

  a month

• Change of grip strength from baseline

  a month

• Change of depression from baseline

  a month

Study Arms (2)

complex decongestive treatment

OTHER

In group 1, the patients were received standard complex decongestive therapy including skin care, manual lymphatic drainage, multi-layer compression bandaging and exercises. During the treatment, written and verbal information was given to the patients about skin care. Manual lymphatic drainage and compressive bandages were applied by a certified physical therapist. The patients received 30-minutes manual lymphatic drainage involving stationary circular, pumping, scooping, and rotary movements. Multi-layer compression bandaging was applied to the affected limb to promote the flow of excess interstitial fluid out of the extremity using a graded pressure for 22-23 hours in a day. The patients strictly followed a lymphoedema exercise program structured with breathing exercise, neck and shoulder range of motion, and stretching exercise to facilitating lymph resorption.

Procedure: complex decongestive therapy

intermittent pneumatic compression

EXPERIMENTAL

In group 2, the patients received experimental intermittent pneumatic compression in addition to the standard complex decongestive therapy. The complex decongestive therapy procedure was the same as above, but additionally, 30 minutes of intermittent pneumatic compression was instituted using a pump (Pulse Press Multi 6 Pro; MJS Healthcare Ltd. UK) operating at 30-40 mmHg of pressure. All groups were given a total of 20 treatment sessions, including daily 5 times a week for 4 weeks.

Device: intermittent pneumatic compression; Procedure: complex decongestive therapy

Interventions

intermittent pneumatic compression DEVICE

intermittent pneumatic compression

complex decongestive therapy PROCEDURE

complex decongestive treatment; intermittent pneumatic compression

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer-related lymphoedema due to unilateral breast cancer
• more than 2 cm difference at the circumference measurements or \>10% difference in volume between the two arms
• completed chemotherapy and radiotherapy

You may not qualify if:

• bilateral breast cancer
• primer lymphoedema
• undergone complex decongestive therapy or other interventions for lymphoedema within 12 months
• truncal and/or breast oedema
• continuing chemotherapy and/or radiotherapy
• active infection
• current metastases
• heart failure with arterial and/or venous occlusion
• elephantiasis
• impaired cognitive status
• received physiotherapy within last six months
• cervical or cranial originated upper extremity problems
• using any medications that affect the body fluid and electrolyte balance

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

MeSH Terms

Conditions

Lymphedema

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 20, 2019
• Study Start: August 17, 2012
• Primary Completion: October 15, 2018
• Study Completion: December 30, 2018
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share