MastectomyNCT06627582
A Study on Pain After Breast Reconstruction
A study testing PROMIS Scale v2.0 - Pain Intensity 3a, PROMIS 29+2 and PROMIS Scale v2.0 - Nociceptive Pain Quality 5a in people with Mastectomy and Mastectomy Patient, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastectomy, Mastectomy Patient, Mastectomy and Breast Reconstruction
- What is being tested?
- PROMIS Scale v2.0 - Pain Intensity 3a, PROMIS 29+2 and PROMIS Scale v2.0 - Nociceptive Pain Quality 5a
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age ≥18 years
- History of mastectomy for breast cancer or genetic predisposition to breast cancer
- History of breast reconstruction with implants and/or autologous tissue
- At least 6 months of follow-up after reconstruction
- Patient treated at MSK
Who cannot join
- Exchange or revision surgery within 6 months
- Active medical reason for pain (e.g., infectious, neoplastic, wound related)
- Greater than 15 years post-reconstruction
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
About this study
Official title: Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction
The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.
- Conditions
- Mastectomy, Mastectomy Patient, Mastectomy and Breast Reconstruction, Breast Reconstruction, Breast Reconstruction After Mastectomy, Postmastectomy Pain
- Being tested
- PROMIS Scale v2.0 - Pain Intensity 3a, PROMIS 29+2, PROMIS Scale v2.0 - Nociceptive Pain Quality 5a, PROMIS Scale v2.0 - Neuropathic Pain Quality 5a
- Keywords
- Postmastectomy Pain, breast reconstruction after mastectomy, breast reconstruction, mastectomy and breast reconstruction, mastectomy, mastectomy patient, 24-271, Memorial Sloan Kettering Cancer Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS Scale v2.0 - Pain Intensity 3aBehavioural
PROMIS Scale v2.0 - Pain Intensity 3a is a 3-question short form in which patients rate their worst, average, and current level of pain during the past 7 days.
PROMIS 29+2Behavioural
PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity
PROMIS Scale v2.0 - Nociceptive Pain Quality 5aBehavioural
5-question short form that identifies patients who have experienced nociceptive pain during the past 7 days
PROMIS Scale v2.0 - Neuropathic Pain Quality 5aBehavioural
5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days
| Study group | Role | What they receive |
|---|---|---|
| Postmastectomy Reconstruction Participants | Experimental | Participants will be postmastectomy reconstruction and >/= 6 months postoperative Receives: Behavioral: PROMIS Scale v2.0 - Pain Intensity 3a; Behavioral: PROMIS 29+2; Behavioral: PROMIS Scale v2.0 - Nociceptive Pain Quality 5a; Behavioral: PROMIS Scale v2.0 - Neuropathic Pain Quality 5a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Persistent Postmastectomy Pain
The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
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 Memorial Sloan Kettering 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Rochlin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627582
- Sponsor's protocol ID
- 24-271
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06627582
- Acronym / sponsor ID
- 24-271
- Conditions
- Mastectomy, Mastectomy Patient, Mastectomy and Breast Reconstruction, Breast Reconstruction, Breast Reconstruction After Mastectomy, Postmastectomy Pain
- Keywords
- Postmastectomy Pain, breast reconstruction after mastectomy, breast reconstruction, mastectomy and breast reconstruction, mastectomy, mastectomy patient, 24-271, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Oct 2024 (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.
The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmastectomy Reconstruction Participants | Experimental | Behavioral: PROMIS Scale v2.0 - Pain Intensity 3a, Behavioral: PROMIS 29+2, Behavioral: PROMIS Scale v2.0 - Nociceptive Pain Quality 5a, Behavioral: PROMIS Scale v2.0 - Neuropathic Pain Quality 5aParticipants will be postmastectomy reconstruction and >/= 6 months postoperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Age ≥18 years
- History of mastectomy for breast cancer or genetic predisposition to breast cancer
- History of breast reconstruction with implants and/or autologous tissue
- At least 6 months of follow-up after reconstruction
Key exclusion criteria (3 listed)
- Exchange or revision surgery within 6 months
- Active medical reason for pain (e.g., infectious, neoplastic, wound related)
- Greater than 15 years post-reconstruction
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 |
|---|---|---|
| PROMIS Scale v2.0 - Pain Intensity 3aPROMIS Scale v2.0 - Pain Intensity 3a is a 3-question short form in which patients rate their worst, average, and current level of pain during the past 7 days. | Behavioural | Postmastectomy Reconstruction Participants |
| PROMIS 29+2PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity | Behavioural | Postmastectomy Reconstruction Participants |
| PROMIS Scale v2.0 - Nociceptive Pain Quality 5a5-question short form that identifies patients who have experienced nociceptive pain during the past 7 days | Behavioural | Postmastectomy Reconstruction Participants |
| PROMIS Scale v2.0 - Neuropathic Pain Quality 5a5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days | Behavioural | Postmastectomy Reconstruction Participants |
Primary outcome
Number of participants with Persistent Postmastectomy Pain
Time frame: up to 6 months
The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Danielle Rochlin, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMIS Scale v2.0 - Pain Intensity 3a, PROMIS 29+2 and PROMIS Scale v2.0 - Nociceptive Pain Quality 5a in people with Mastectomy and Mastectomy Patient, run by Memorial Sloan Kettering Cancer Center at 7 sites 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with Persistent Postmastectomy Pain (time frame: up to 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 27 Mar 2026.