Treatment of Postmastectomy Pain Syndrome With Fat Grafting

Odense University Hospital

Status: Completed

Conditions: Post-Mastectomy Chronic Pain Syndrome (Disorder)

Treatments: Procedure: Sham graft (saline injection); Procedure: Fat graft; Procedure: Liposuction

Study type: Interventional

Funder types: Other

Identifiers

NCT03081286

S-20160185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Fat grafting

Experimental group

Description:

Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery.

Treatment:

Procedure: Liposuction

Procedure: Fat graft

Sham grafting

Sham Comparator group

Description:

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.

Treatment:

Procedure: Liposuction

Procedure: Sham graft (saline injection)