Post-Mastectomy Chronic Pain Syndrome (Disorder)NCT03081286
Treatment of Postmastectomy Pain Syndrome With Fat Grafting
A study testing Liposuction and Fat graft in people with Post-Mastectomy Chronic Pain Syndrome (Disorder), run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Mastectomy Chronic Pain Syndrome (Disorder)
- What is being tested?
- Liposuction and Fat graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Liposuction, Fat graft, Sham graft (saline injection)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
Fat graftProcedure or surgery
Also called lipotransfer
The harvested lipoaspirate is injected at the site of pain.
Sham graft (saline injection)Procedure or surgery
Saline will be injected at the site of pain instead of fat
| Study group | Role | What they receive |
|---|---|---|
| Fat grafting | Experimental | Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery. Receives: 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. Receives: Procedure: Liposuction; Procedure: Sham graft (saline injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on visual analog scale (VAS) 0-10
Pain on visual analog scale (VAS) 0-10
Measured: 6 months
Secondary outcomes (3)
Neuropathic Pain Symptom Inventory
Questionnaire
Measured: 3 and 6 months
Use of pain medication
pain medication used is registered on questionnaire
Measured: 3 and 6 months
Pain on visual analog scale (VAS) 0-10
Pain on visual analog scale (VAS) 0-10
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Aug 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Mastectomy Chronic Pain Syndrome (Disorder)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Sollie, Odense University Hospital
- Investigators
- Jens A Sørensen, MD PhD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081286
- Sponsor's protocol ID
- S-20160185
- Status last verified
- Sep 2020
- First submitted
- 2 Mar 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03081286
- Acronym / sponsor ID
- S-20160185
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fat grafting | Experimental | Procedure: Liposuction, Procedure: Fat graftFollowing liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery. |
| Sham grafting | Sham comparator | Procedure: Liposuction, Procedure: Sham graft (saline injection)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiposuctionLiposuction is performed on the abdomen or thighs as determined before randomization by the surgeon. | Procedure or surgery | Fat grafting, Sham grafting |
| Fat graftAlso: lipotransferThe harvested lipoaspirate is injected at the site of pain. | Procedure or surgery | Fat grafting |
| Sham graft (saline injection)Saline will be injected at the site of pain instead of fat | Procedure or surgery | Sham grafting |
Primary outcome
Pain on visual analog scale (VAS) 0-10
Time frame: 6 months
Pain on visual analog scale (VAS) 0-10
3 secondary outcomes
Neuropathic Pain Symptom Inventory
Time frame: 3 and 6 months
Use of pain medication
Time frame: 3 and 6 months
Pain on visual analog scale (VAS) 0-10
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Recruiting
Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain
Pulsed Radiofrequency, Shoulder Individual Nerves Brachial Plexus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens A Sørensen, MD PhD study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposuction and Fat graft in people with Post-Mastectomy Chronic Pain Syndrome (Disorder), run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on visual analog scale (VAS) 0-10 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.