Treatment of Postmastectomy Pain Syndrome With Fat Grafting
NCT ID: NCT03081286
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-08-01
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fat grafting
Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery.
Liposuction
Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
Fat graft
The harvested lipoaspirate is injected at the site of pain.
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.
Liposuction
Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
Sham graft (saline injection)
Saline will be injected at the site of pain instead of fat
Interventions
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Liposuction
Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
Fat graft
The harvested lipoaspirate is injected at the site of pain.
Sham graft (saline injection)
Saline will be injected at the site of pain instead of fat
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Recurrence of breast cancer at any time.
* Other indication for fat grafting other than pain treatment.
* Breast reconstruction with flap
18 Years
FEMALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Martin Sollie
Doctor
Principal Investigators
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Jens A Sørensen, MD PhD
Role: STUDY_CHAIR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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S-20160185
Identifier Type: -
Identifier Source: org_study_id
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