Treatment of Postmastectomy Pain Syndrome With Fat Grafting

September 14, 2020 updated by: Martin Sollie, Odense University Hospital

Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial

This study evaluates the possible beneficial effect of fat grafting for post mastectomy pain syndrome. Half of patients will receive fat grafting and the other half of patients will receive sham.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several studies have suggested that fat grafting can alleviate pain in post mastectomy pain syndrome. These studies however have either been in the form of case series or unblinded studies with great risk of bias.

It is believed that fat grafting with its content of adipose-derived stem cells can modulate the scar tissue upon grafting and hereby decrease pain.

In this study patients will be randomized to either fat grafting or a sham procedure where they undergo the same liposuction but no fat grafting, only injection of saline instead of fat.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Treated for breast cancer
  • Pain in the breast cancer treated area on the breast or axilla.
  • Pain present at least 4 days a week with an intensity above 3 on VAS.
  • Duration longer than 3 months
  • Recurrence free for minimum 6 months
  • Understand the nature of the study and can give informed consent

Exclusion Criteria:

  • Psychiatric condition that can affect participation.
  • Recurrence of breast cancer at any time.
  • Other indication for fat grafting other than pain treatment.
  • Breast reconstruction with flap

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fat grafting
Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery.
Procedure: Liposuction
Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
Procedure: Fat graft
The harvested lipoaspirate is injected at the site of pain.
Other Names:
  • lipotransfer
SHAM_COMPARATOR: Sham grafting
Following liposuction the fat is discarded. Instead approximately 50mL of saline is used instead of fat and injected into the area of pain after breast cancer surgery.
Procedure: Liposuction
Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
Procedure: Sham graft (saline injection)
Saline will be injected at the site of pain instead of fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on visual analog scale (VAS) 0-10
Time Frame: 6 months
Pain on visual analog scale (VAS) 0-10
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Symptom Inventory
Time Frame: 3 and 6 months
Questionnaire
3 and 6 months
Use of pain medication
Time Frame: 3 and 6 months
pain medication used is registered on questionnaire
3 and 6 months
Pain on visual analog scale (VAS) 0-10
Time Frame: 3 months
Pain on visual analog scale (VAS) 0-10
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 months
Any complications following treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Chair: Jens A Sørensen, MD PhD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

July 31, 2020

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (ACTUAL)

March 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20160185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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