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Treatment of Postmastectomy Pain Syndrome With Fat Grafting

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03081286
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
36
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Liposuction
  • Procedure: Fat graft
  • Procedure: Sham graft (saline injection)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
During general anesthesia, patients are randomized to either fat grafting or sham grafting with only saline. All patients undergo the same liposuction. Participants are blinded, care providers postoperatively are blinded. The surgeon performing the procedure is not blinded. The outcome assessors 3 and 6 months postoperatively are blinded.
Primary Purpose:
Treatment
Official Title:
Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Jul 31, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Pain on visual analog scale (VAS) 0-10 [6 months]

      Pain on visual analog scale (VAS) 0-10

    Secondary Outcome Measures

    1. Neuropathic Pain Symptom Inventory [3 and 6 months]

      Questionnaire

    2. Use of pain medication [3 and 6 months]

      pain medication used is registered on questionnaire

    3. Pain on visual analog scale (VAS) 0-10 [3 months]

      Pain on visual analog scale (VAS) 0-10

    Other Outcome Measures

    1. Complications [3 months]

      Any complications following treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martin Sollie, Doctor, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT03081286
    Other Study ID Numbers:
    • S-20160185
    First Posted:
    Mar 16, 2017
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Syndrome
    Chronic Pain
    Somatoform Disorders

    Study Results

    No Results Posted as of Sep 16, 2020