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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03081286 |
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Date of registration:
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02/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Postmastectomy Pain Syndrome With Fat Grafting
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Scientific title:
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Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial |
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Date of first enrolment:
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August 1, 2017 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03081286 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jens A Sørensen, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odense University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Post-Mastectomy Chronic Pain Syndrome (Disorder)
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Intervention(s)
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Procedure: Fat graft
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Procedure: Liposuction
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Procedure: Sham graft (saline injection)
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Primary Outcome(s)
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Pain on visual analog scale (VAS) 0-10
[Time Frame: 6 months]
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Secondary Outcome(s)
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Pain on visual analog scale (VAS) 0-10
[Time Frame: 3 months]
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Neuropathic Pain Symptom Inventory
[Time Frame: 3 and 6 months]
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Use of pain medication
[Time Frame: 3 and 6 months]
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Secondary ID(s)
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S-20160185
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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