MastectomyNCT03135392
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
A study testing Breast Reconstruction with Artificial Implant, Autologous Breast Reconstruction and Neurotization in people with Mastectomy and Breast Reconstruction, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy. Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Breast Reconstruction
- What is being tested?
- Breast Reconstruction with Artificial Implant, Autologous Breast Reconstruction and Neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2018to Oct 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
- Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer
- Patient must have one of the following reconstructions in planned:
- Immediate tissue expander placement
- Immediate implant placement
- Immediate autologous breast reconstruction
- All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit.
Who cannot join
- Pre-operative radiation therapy
- Any pre-excising
- Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Return of Breast Sensation Following Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer: An Evaluation of Clinical, Sensory, and Quality of Life Outcomes
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.
Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.
Read the detailed description
To determine the timing and distribution of sensation recovery of breast after mastectomy and breast reconstruction, both with autologous and implant-based reconstruction. Also, to determine the role of innervated free tissue transfer in breast reconstruction.
Specific Aims
- Determine the timing and degree of return of breast in women who underwent mastectomy with autologous tissue or with implant based reconstruction.
- Determine sensation following neurotized free flap reconstruction
- Determine whether neurotization has an impact on quality of life measures post operatively
Study Design Patients will be enrolled prospectively in this data collection study in which they will receive the standard of care for breast cancer resection and oncologically safe and accepted means of breast reconstruction with tissue expander and/or prosthetic implants. Patients will receive additional, non-invasive sensory testing, performed at standard follow up intervals in clinic by their reconstructive team. All patients participating in the study will be consented for enrollment at the pre-operative visit by either the surgeon or physician assistant. As this is a prospective study, all women fitting inclusion criteria over a 6-month minimal, but projected goal 12-month period will be included.
- Conditions
- Mastectomy, Breast Reconstruction
- Being tested
- Breast Reconstruction with Artificial Implant, Autologous Breast Reconstruction, Neurotization
- Keywords
- Breast Cancer, sensation recovery, Neurotization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Reconstruction with Artificial ImplantProcedure or surgery
Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants
Autologous Breast ReconstructionProcedure or surgery
Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue
NeurotizationProcedure or surgery
Also called Nerve Reconstruction
Nerve will be reconstructed during autologous breast tissue reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Breast Reconstruction with Artificial Implant | Active comparator | Participants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts Receives: Procedure: Breast Reconstruction with Artificial Implant |
| Autologous Breast Reconstruction without Neurotization | Active comparator | Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery Receives: Procedure: Autologous Breast Reconstruction |
| Autologous Breast Reconstruction with Neurotization | Experimental | Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery. Receives: Procedure: Autologous Breast Reconstruction; Procedure: Neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of sensation
Differences of at least 20% comparing control to experimental breasts would be clinically meaningful. Composite measure will be calculated by combining the follow binomial factors: detection of temperature difference (feeling hot and cold), detection of sharp versus dull pressure, detection of vibration, discerning point pressure
Measured: Up to 24 months after surgery
Secondary outcomes (1)
Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast.
A total of 19 Likert scale questions will be given to participants in the pre- and post-Surgical Sensation Questionnaire regarding sensation and appearance of breast before and after reconstruction.
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startOct 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Research cancelled because of inadequate staffing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective cohort study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Moreira, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135392
- Sponsor's protocol ID
- CASE2117
- Status last verified
- Nov 2018
- First submitted
- 27 Apr 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return of Breast Sensation Following Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer: An Evaluation of Clinical, Sensory, and Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT03135392
- Acronym / sponsor ID
- CASE2117
- Conditions
- Mastectomy, Breast Reconstruction
- Keywords
- Breast Cancer, sensation recovery, Neurotization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research cancelled because of inadequate staffing.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 1 May 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.
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.
Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.
Detailed description
To determine the timing and distribution of sensation recovery of breast after mastectomy and breast reconstruction, both with autologous and implant-based reconstruction. Also, to determine the role of innervated free tissue transfer in breast reconstruction.
Specific Aims
- Determine the timing and degree of return of breast in women who underwent mastectomy with autologous tissue or with implant based reconstruction.
- Determine sensation following neurotized free flap reconstruction
- Determine whether neurotization has an impact on quality of life measures post operatively
Study Design Patients will be enrolled prospectively in this data collection study in which they will receive the standard of care for breast cancer resection and oncologically safe and accepted means of breast reconstruction with tissue expander and/or prosthetic implants. Patients will receive additional, non-invasive sensory testing, performed at standard follow up intervals in clinic by their reconstructive team. All patients participating in the study will be consented for enrollment at the pre-operative visit by either the surgeon or physician assistant. As this is a prospective study, all women fitting inclusion criteria over a 6-month minimal, but projected goal 12-month period will be included.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Breast Reconstruction with Artificial Implant | Active comparator | Procedure: Breast Reconstruction with Artificial ImplantParticipants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts |
| Autologous Breast Reconstruction without Neurotization | Active comparator | Procedure: Autologous Breast ReconstructionParticipants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery |
| Autologous Breast Reconstruction with Neurotization | Experimental | Procedure: Autologous Breast Reconstruction, Procedure: NeurotizationParticipants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during 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)
- Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer
- Patient must have one of the following reconstructions in planned:
- All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit.
Key exclusion criteria (3 listed)
- Pre-operative radiation therapy
- Any pre-excising
- Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"
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 |
|---|---|---|
| Breast Reconstruction with Artificial ImplantPatients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants | Procedure or surgery | Breast Reconstruction with Artificial Implant |
| Autologous Breast ReconstructionPatients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue | Procedure or surgery | Autologous Breast Reconstruction with Neurotization, Autologous Breast Reconstruction without Neurotization |
| NeurotizationAlso: Nerve ReconstructionNerve will be reconstructed during autologous breast tissue reconstruction | Procedure or surgery | Autologous Breast Reconstruction with Neurotization |
Primary outcome
Composite measure of sensation
Time frame: Up to 24 months after surgery
Differences of at least 20% comparing control to experimental breasts would be clinically meaningful. Composite measure will be calculated by combining the follow binomial factors: detection of temperature difference (feeling hot and cold), detection of sharp versus dull pressure, detection of vibration, discerning point pressure
1 secondary outcome
Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast.
Time frame: Up to 24 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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.
Andrea Moreira, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Reconstruction with Artificial Implant, Autologous Breast Reconstruction and Neurotization in people with Mastectomy and Breast Reconstruction, run by Case Comprehensive Cancer Center at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 14 Nov 2018. 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Composite measure of sensation (time frame: Up to 24 months after surgery). 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 14 Nov 2018.