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

NCT03776721 | Completed Phase 2 DMC

• 1 other identifier: S-20180117
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Change in arm volume

  Assessed using clinical circumference measurement

  Baseline, 3, 6, 9 and 12 months

Secondary Outcomes (9)

• Safety of treatments: Assessed by asking the patient at each visit

  Baseline, 3, 6, 9 and 12 months

• Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire

  Baseline, 3, 6, 9 and 12 months

• Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire

  Baseline, 3, 6, 9 and 12 months

• Subjective changes assessed using SF-36 questionnaire

  Baseline, 3, 6, 9 and 12 months

• Change in lymph drainage

  Baseline and 12 months

Study Arms (2)

Active treatment

EXPERIMENTAL

Procedure: Liposuction; Procedure: Fat graft; Biological: Stem cell injection

Placebo treatment

PLACEBO COMPARATOR

Procedure: Liposuction; Procedure: Sham graf (Saline injection); Procedure: Saline injection

Interventions

Liposuction PROCEDURE

Liposuction is performed on the abdomen or thighs.

Active treatment; Placebo treatment

Fat graft PROCEDURE

30mL harvested lipoaspirate is injected at the affected axillary site.

Also known as: lipotransfer

Active treatment

Sham graf (Saline injection) PROCEDURE

30mL saline is injected at the affected axillary site.

Placebo treatment

Stem cell injection BIOLOGICAL

4mL stem cell suspension injected at the affected axillary site.

Active treatment

Saline injection PROCEDURE

4mL saline injected at the affected axillary site.

Placebo treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Plastic and Reconstructive Surgery

Odense, 5000, Denmark

Location

Related Publications (1)

• Jorgensen MG, Jensen CH, Hermann AP, Andersen DC, Toyserkani NM, Sheikh SP, Sorensen JA. No Clinical Efficacy of Adipose-Derived Regenerative Cells and Lipotransfer in Breast Cancer-Related Lymphedema: A Double-Blind Placebo-Controlled Phase II Trial. Plast Reconstr Surg. 2024 Dec 1;154(6):1172-1182. doi: 10.1097/PRS.0000000000011343. Epub 2024 Feb 7.

  PMID: 39591365 DERIVED

MeSH Terms

Conditions

Lymphedema

Interventions

Lipectomy; Sodium Chloride

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jens A Sørensen, MD, PhD

  Department of Plastic Surgery, Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients undergo the same liposuction procedure. During general anesthesia, patients are randomized to either fat grafting or sham grafting with saline injection to the axilla. After stem cell suspension, patients receive either stem cell or saline injection depending on randomization using masked syringes. Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 17, 2018
• Study Start: December 18, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

DK (1)