Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Phase 2

Completed

• Conditions: Lymphedema
• Interventions: Procedure: Liposuction; Procedure: Sham graf (Saline injection); Procedure: Fat graft; Biological: Stem cell injection; Procedure: Saline injection

• Registration Number: NCT03776721
• Lead Sponsor: Odense University Hospital

Brief Summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-17
• Study Start: 2018-12-18
• Status Verified: 2021-06
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Last Update Submitted: 2021-06-24
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
• Cancer free for at least 1 year
• The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
• The opposite upper extremity is healthy (no lymphedema).
• ASA score of 1 or 2.
• The patient is able to read, understand, and complete Danish questionnaires.
• Pitting lymphedema ISL grade 1 or 2.
• A minimum circumference difference of 2cm or a minimum volume difference of 200mL.

Read More

Exclusion Criteria

• Pregnant or lactating.
• Bilateral lymphedema
• Current or previous malignancies other than breast cancer.
• Insulin-dependent diabetes.
• Diagnosed with any form of psychotic disorder, which may impact study participation.
• Not ceased smoking during treatment.
• Active implantables (e.g. pacemaker or neurostimulator)
• Unrealistic treatment expectations.
• Known hepatitis, HIV or syphilis infection.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment	Liposuction	-
Placebo treatment	Sham graf (Saline injection)	-
Active treatment	Stem cell injection	-
Placebo treatment	Liposuction	-
Active treatment	Fat graft	-
Placebo treatment	Saline injection	-

Primary Outcome Measures

Name	Time	Method
Change in arm volume	Baseline, 3, 6, 9 and 12 months	Assessed using clinical circumference measurement

Secondary Outcome Measures

Name	Time	Method
Safety of treatments: Assessed by asking the patient at each visit	Baseline, 3, 6, 9 and 12 months	Any side effects to treatments. Assessed by asking the patient at each visit.
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire	Baseline, 3, 6, 9 and 12 months	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire	Baseline, 3, 6, 9 and 12 months	Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Subjective changes assessed using SF-36 questionnaire	Baseline, 3, 6, 9 and 12 months	Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.
Change in lymph drainage	Baseline and 12 months	Change in lymph drainage assessed by indocyanine-green lymphangiography
Change in conservative lymphedema treatment	Baseline, 3, 6, 9 and 12 months	Change in use or type of conservative lymphedema treatments
Change in adverse lymphedema-related events	Baseline, 3, 6, 9 and 12 months	Change in infection rates and sick-days due to lymphedema.
Change in L-DEX score (bioimpedance)	Baseline, 3, 6, 9 and 12 months	Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.
Change in weight and arm tissue composition	Baseline, 3, 6, 9 and 12 months	Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.

Trial Locations

Locations (1)

Department of Plastic and Reconstructive Surgery; 🇩🇰 Odense, Denmark