Treatment of Postmastectomy Pain Syndrome With Fat Grafting

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: Post-Mastectomy Chronic Pain Syndrome (Disorder)
• Intervention / Treatment: Procedure: Liposuction; Procedure: Fat graft; Procedure: Sham graft (saline injection)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Pain on visual analog scale (VAS) 0-10	6 months

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Chronic Pain; Somatoform Disorders
• 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