Treatment of Postmastectomy Pain Syndrome With Fat Grafting

Not Applicable

Completed

• Conditions: Post-Mastectomy Chronic Pain Syndrome (Disorder)
• Interventions: Procedure: Liposuction; Procedure: Fat graft; Procedure: Sham graft (saline injection)

• Registration Number: NCT03081286
• Lead Sponsor: Odense University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Study Start: 2017-08-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fat grafting	Fat graft	Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery.
Fat grafting	Liposuction	Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery.
Sham grafting	Liposuction	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.
Sham grafting	Sham graft (saline injection)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark