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NCT Number: NCT03081286

Treatment of Postmastectomy Pain Syndrome With Fat Grafting

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.

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Key information

Conditions

Post-Mastectomy Chronic Pain Syndrome (Disorder)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposuction

Procedure

Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.

Fat graft

Procedure

The harvested lipoaspirate is injected at the site of pain.

Other names: lipotransfer

Sham graft (saline injection)

Procedure

Saline will be injected at the site of pain instead of fat

Primary outcomes

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

    Time frame: 6 months

    Pain on visual analog scale (VAS) 0-10

Secondary outcomes

  1. Neuropathic Pain Symptom Inventory

    Time frame: 3 and 6 months

    Questionnaire

  2. Use of pain medication

    Time frame: 3 and 6 months

    pain medication used is registered on questionnaire

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

    Time frame: 3 months

    Pain on visual analog scale (VAS) 0-10

Other outcomes

  1. Complications

    Time frame: 3 months

    Any complications following treatment

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2017
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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