Treatment of Postmastectomy Pain Syndrome With Fat Grafting

Post-Mastectomy Chronic Pain Syndrome (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081286
• Other study ID #: S-20160185
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Post-Mastectomy Chronic Pain Syndrome (Disorder)
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Any complications following treatment	3 months
Primary	Pain on visual analog scale (VAS) 0-10	Pain on visual analog scale (VAS) 0-10	6 months
Secondary	Neuropathic Pain Symptom Inventory	Questionnaire	3 and 6 months
Secondary	Use of pain medication	pain medication used is registered on questionnaire	3 and 6 months
Secondary	Pain on visual analog scale (VAS) 0-10	Pain on visual analog scale (VAS) 0-10	3 months