Treatment of Postmastectomy Pain Syndrome With Fat Grafting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-Mastectomy Chronic Pain Syndrome (Disorder)

Intervention / Treatment
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* Procedure: Liposuction
* Procedure: Fat graft
* Procedure: Sham graft (saline injection)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fat grafting<br>Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery. | Procedure: Liposuction<br>* Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.<br>Procedure: Fat graft<br>* The harvested lipoaspirate is injected at the site of pain.<br>* Other names: lipotransfer;|
| Sham Comparator: Sham grafting<br>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<br>* Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.<br>Procedure: Sham graft (saline injection)<br>* Saline will be injected at the site of pain instead of fat<br>|

What is the study measuring?
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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 |