Treatment of Postmastectomy Pain Syndrome With Fat Grafting

NCT03081286 | Completed DMC

• 1 other identifier: S-20160185
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Mastectomy Chronic Pain Syndrome (Disorder)

Outcome Measures

Primary Outcomes (1)

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

  Pain on visual analog scale (VAS) 0-10

  6 months

Secondary Outcomes (3)

• Neuropathic Pain Symptom Inventory

  3 and 6 months

• Use of pain medication

  3 and 6 months

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

  3 months

Other Outcomes (1)

• Complications

  3 months

Study Arms (2)

Fat grafting

EXPERIMENTAL

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

Procedure: Liposuction; Procedure: Fat graft

Sham grafting

SHAM COMPARATOR

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; Procedure: Sham graft (saline injection)

Interventions

Liposuction PROCEDURE

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

Fat grafting; Sham grafting

Fat graft PROCEDURE

The harvested lipoaspirate is injected at the site of pain.

Also known as: lipotransfer

Fat grafting

Sham graft (saline injection) PROCEDURE

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

Sham grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

Lipectomy; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jens A Sørensen, MD PhD

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 16, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)