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Treatment of Postmastectomy Pain Syndrome With Fat Grafting

Primary Purpose

Post-Mastectomy Chronic Pain Syndrome (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Liposuction
Fat graft
Sham graft (saline injection)
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Mastectomy Chronic Pain Syndrome (Disorder)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Fat grafting

Sham grafting

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pain on visual analog scale (VAS) 0-10
Pain on visual analog scale (VAS) 0-10

Secondary Outcome Measures

Neuropathic Pain Symptom Inventory
Questionnaire
Use of pain medication
pain medication used is registered on questionnaire
Pain on visual analog scale (VAS) 0-10
Pain on visual analog scale (VAS) 0-10

Full Information

First Posted
March 2, 2017
Last Updated
September 14, 2020
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03081286
Brief Title
Treatment of Postmastectomy Pain Syndrome With Fat Grafting
Official Title
Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Mastectomy Chronic Pain Syndrome (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fat grafting
Arm Type
Experimental
Arm Description
Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery.
Arm Title
Sham grafting
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Description
Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
Intervention Type
Procedure
Intervention Name(s)
Fat graft
Other Intervention Name(s)
lipotransfer
Intervention Description
The harvested lipoaspirate is injected at the site of pain.
Intervention Type
Procedure
Intervention Name(s)
Sham graft (saline injection)
Intervention Description
Saline will be injected at the site of pain instead of fat
Primary Outcome Measure Information:
Title
Pain on visual analog scale (VAS) 0-10
Description
Pain on visual analog scale (VAS) 0-10
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Neuropathic Pain Symptom Inventory
Description
Questionnaire
Time Frame
3 and 6 months
Title
Use of pain medication
Description
pain medication used is registered on questionnaire
Time Frame
3 and 6 months
Title
Pain on visual analog scale (VAS) 0-10
Description
Pain on visual analog scale (VAS) 0-10
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Complications
Description
Any complications following treatment
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens A Sørensen, MD PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Postmastectomy Pain Syndrome With Fat Grafting

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