Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT07206394
Feasibility Trial of ScarWork for Post-breast Surgery Pain Syndrome.
A study testing ScarWork therapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
Breast cancer is the most common cancer in women in the United Kingdom (UK). Most women are treated with a combination of surgery and radiotherapy. While these treatments are effective, they can cause ongoing breast pain for some, which can last months or even years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- ScarWork therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2025to 30 Jun 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18
- Early breast cancer patients who have had breast surgery with curative intent
- Radiotherapy completed ≥ 6 months previously
- In remission with no sign of active local disease
- Registering a score of ≥3 on perceived pain intensity or pain burden on a 10-point numerical rating scale (NRS)
- English speaking and able to communicate reasonably well
- Able to give informed consent
- Willing to attend for regular treatment at RLHIM
Who cannot join
- History of post-breast surgery wound complications
- History of breast surgery unrelated to breast cancer treatment
- History of previous ScarWork therapy
- Diagnosis of lymphoedema
- Severe co-morbidities or cognitive disability
- Receiving physiotherapy for post-breast surgery pain syndrome at the time of trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital for Integrated Medicine
London
Nicole Collaco, +4489 484 435 22, nicole.collaco@nhs.net
John Hughes, john.hughes8@nhs.net
About this study
Official title: A Feasibility Trial of ScarWork on Post-breast Surgery Pain Syndrome (PBSPS) in Early Stage Breast Cancer Patients.
Breast cancer is the most common cancer in women in the United Kingdom (UK). Most women are treated with a combination of surgery and radiotherapy. While these treatments are effective, they can cause ongoing breast pain for some, which can last months or even years. This long-term pain can have a major impact on quality of life, yet it is often overlooked and not well managed in routine care.
One in three women may still experience breast pain three years after treatment. The pain can come from scarring, tissue damage, or nerve changes caused by surgery and radiotherapy. Treatments for this pain are limited. Many patients are advised the pain will subside on its own or are given basic painkillers, which sometimes have limited impact.
Read more
ScarWork is a light-touch manual therapy, developed in the United States and aims to improve the way scars feel and look, reduce pain and tightness, and support healing. Although it has been available in the United Kingdom since 2014, there is very little research into whether ScarWork helps people who experience pain after breast cancer treatment.
This small study is a first step to see whether ScarWork could be a useful treatment for people who have experience breast pain after surgery and/or radiotherapy. The researchers want to know:
- Can this therapy be delivered in an NHS setting?
- Do people find it helpful?
- Is it worth doing a larger trial in the future?
Participants will be randomly placed in one of two groups: one group will continue with usual care, and the other will receive up to five sessions of ScarWork in addition to usual care. Everyone in the study will be asked to complete short questionnaires about their pain and other symptoms, before and after treatment, and again one month later. Participants will also be invited to talk about their experiences in a short phone or online interview.
This research will help show whether ScarWork might be a useful option for people dealing with breast pain after treatment. It will also help researchers design a larger trial in the future to test ScarWork more fully.
Read the detailed description
Background Breast cancer is the most common cancer among women in the United Kingdom (UK). Each year, around 57,000 women are diagnosed. Many are treated with a combination of breast-conserving surgery (also known as a lumpectomy) and radiotherapy. These treatments are highly effective but can result in significant trauma to the breast tissue and skin, leading to long-term pain for some individuals.
Although short-term pain after surgery and radiotherapy is expected, some people go on to experience persistent and sometimes worsening pain long after the area has healed. This condition, often referred to as Post-Breast Surgery Pain Syndrome (PBSPS), can interfere with day-to-day life, emotional wellbeing, and recovery. Research suggests that as many as 40% of women still experience breast pain up to three years after treatment.
Despite this, there are currently few treatment options specifically targeting PBSPS. Most patients are offered basic pain relief or reassured that the pain will eventually fade. Surveys show that while most breast cancer specialists recognize this pain as a common issue, less than half routinely offer specific treatment for it.
ScarWork is a manual light touch therapy technique developed by therapist Sharon Wheeler in the United States. It involves gentle, targeted touch of scar tissue with the goal of improving tissue mobility, reducing pain and discomfort, and supporting healing. ScarWork has been used in the United Kingdom since 2014, but very little scientific research has been done to evaluate how effective it is, particularly for people experiencing post-surgery breast pain.
A previous evaluation found that cancer survivors who received ScarWork reported less pain, improved scar appearance and sensation, and a general reduction in symptoms. However, these findings were based on an early-stage service evaluation rather than a formal clinical trial.
About this study This feasibility study is designed to explore whether ScarWork can help people with early-stage breast cancer who are living with breast pain following surgery and/or radiotherapy. It will also assess whether delivering ScarWork within an NHS setting is practical and acceptable for both patients and healthcare providers.
The study is based at University College London Hospitals (UCLH) and is the first of its kind to investigate the use of ScarWork specifically for PBSPS in people treated with breast surgery.
Study design
Participants in this study will be randomly assigned to one of two groups:
- Standard care only, or
- Standard care plus ScarWork therapy (up to five individualised ScarWork sessions)
The ScarWork treatment will be tailored to each participant's needs, in keeping with typical clinical practice. Outcome measures will be collected at the beginning of the study, after the final ScarWork session, and again four weeks after the treatment ends. This will help the research team assess both immediate and longer-term effects of the therapy.
Participants will complete questionnaires about their pain, scar-related symptoms, and general wellbeing. They will be able to complete these online, by post, or over the phone with a researcher. Those in the ScarWork group may also be invited to take part in a short interview to share their experiences of the treatment and the study process.
The findings will help researchers decide whether a larger, more detailed clinical trial is possible and worthwhile in the future.
Importance of study Pain after breast cancer treatment is common but under-recognised and under-treated. This study addresses an important gap in care by exploring a therapy that could provide relief to thousands of people living with post-treatment pain. By assessing ScarWork in a structured NHS setting, the study also helps build evidence for how complementary therapies can be integrated into cancer aftercare in a safe and measured way.
- Being tested
- ScarWork therapy
- Keywords
- breast cancer, ScarWork, feasibility study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScarWork therapyOther
ScarWork is a manual therapy technique involving gentle, hands-on massage of scar tissue. It is designed to improve the mobility and integration of scar tissue, reduce discomfort, and support tissue healing. The approach is tailored to each individual, based on the characteristics of their scar and sensitivity of the surrounding tissue. It is commonly used with people recovering from surgery or radiotherapy to help address symptoms such as pain, tightness, numbness, or altered sensation. In this study, participants in the intervention group will receive up to five ScarWork sessions delivered by a trained therapist, in addition to standard care.
| Study group | Role | What they receive |
|---|---|---|
| ScarWork plus standard care | Active comparator | Participant received up to 5 ScarWork sessions alongside usual standard of care Receives: Other: ScarWork therapy |
| Standard care | No intervention | Participants continue with their usual standard of care and symptom management without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREAST-Q Breast Conserving Therapy Module V2.0
A validated patient-reported outcome measure designed to evaluate outcomes among women undergoing breast conserving therapy, with the two overarching domains of 1) health-related quality of life and 2) patient satisfaction. Scales can be used selectively as appropriate to the research. For this study, we will measure:
- Quality of life domains using:
- Psychosocial Well-being scale comprises 10 items that ask about body image and a woman's confidence in social settings, as well as emotional health and self esteem.
- Sexual Well-being scale comprises 6 items that ask about feelings of sexual attractiveness and confidence relating to breasts.
- Physical Well-being
- Chest scale comprises 9 items measuring problems in the breast area (tightness, pulling, tenderness, pain), activity limitations and sleep problems due to discomfort.
- Adverse Effects of Radiation scale
- Satisfaction with Breasts
Measured: Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start20 Jun 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will employ a pragmatic mixed methods randomised parallel-group exploratory design.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University of West London
- Responsible party
- Principal investigator, John Hughes, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206394
- Sponsor's protocol ID
- 352185
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality, as the dataset includes sensitive health information related to scar treatment outcomes. Aggregate or de-identified data may be available on request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of ScarWork on Post-breast Surgery Pain Syndrome (PBSPS) in Early Stage Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT07206394
- Acronym / sponsor ID
- 352185
- Keywords
- breast cancer, ScarWork, feasibility study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- University of West London
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Oct 2025 (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.
Breast cancer is the most common cancer in women in the United Kingdom (UK). Most women are treated with a combination of surgery and radiotherapy. While these treatments are effective, they can cause ongoing breast pain for some, which can last months or even years. This long-term pain can have a major impact on quality of life, yet it is often overlooked and not well managed in routine care.
One in three women may still experience breast pain three years after treatment. The pain can come from scarring, tissue damage, or nerve changes caused by surgery and radiotherapy. Treatments for this pain are limited. Many patients are advised the pain will subside on its own or are given basic painkillers, which sometimes have limited impact.
ScarWork is a light-touch manual therapy, developed in the United States and aims to improve the way scars feel and look, reduce pain and tightness, and support healing. Although it has been available in the United Kingdom since 2014, there is very little research into whether ScarWork helps people who experience pain after breast cancer treatment.
This small study is a first step to see whether ScarWork could be a useful treatment for people who have experience breast pain after surgery and/or radiotherapy. The researchers want to know:
- Can this therapy be delivered in an NHS setting?
- Do people find it helpful?
- Is it worth doing a larger trial in the future?
Participants will be randomly placed in one of two groups: one group will continue with usual care, and the other will receive up to five sessions of ScarWork in addition to usual care. Everyone in the study will be asked to complete short questionnaires about their pain and other symptoms, before and after treatment, and again one month later. Participants will also be invited to talk about their experiences in a short phone or online interview.
This research will help show whether ScarWork might be a useful option for people dealing with breast pain after treatment. It will also help researchers design a larger trial in the future to test ScarWork more fully.
Detailed description
Background Breast cancer is the most common cancer among women in the United Kingdom (UK). Each year, around 57,000 women are diagnosed. Many are treated with a combination of breast-conserving surgery (also known as a lumpectomy) and radiotherapy. These treatments are highly effective but can result in significant trauma to the breast tissue and skin, leading to long-term pain for some individuals.
Although short-term pain after surgery and radiotherapy is expected, some people go on to experience persistent and sometimes worsening pain long after the area has healed. This condition, often referred to as Post-Breast Surgery Pain Syndrome (PBSPS), can interfere with day-to-day life, emotional wellbeing, and recovery. Research suggests that as many as 40% of women still experience breast pain up to three years after treatment.
Despite this, there are currently few treatment options specifically targeting PBSPS. Most patients are offered basic pain relief or reassured that the pain will eventually fade. Surveys show that while most breast cancer specialists recognize this pain as a common issue, less than half routinely offer specific treatment for it.
ScarWork is a manual light touch therapy technique developed by therapist Sharon Wheeler in the United States. It involves gentle, targeted touch of scar tissue with the goal of improving tissue mobility, reducing pain and discomfort, and supporting healing. ScarWork has been used in the United Kingdom since 2014, but very little scientific research has been done to evaluate how effective it is, particularly for people experiencing post-surgery breast pain.
A previous evaluation found that cancer survivors who received ScarWork reported less pain, improved scar appearance and sensation, and a general reduction in symptoms. However, these findings were based on an early-stage service evaluation rather than a formal clinical trial.
About this study This feasibility study is designed to explore whether ScarWork can help people with early-stage breast cancer who are living with breast pain following surgery and/or radiotherapy. It will also assess whether delivering ScarWork within an NHS setting is practical and acceptable for both patients and healthcare providers.
The study is based at University College London Hospitals (UCLH) and is the first of its kind to investigate the use of ScarWork specifically for PBSPS in people treated with breast surgery.
Study design
Participants in this study will be randomly assigned to one of two groups:
- Standard care only, or
- Standard care plus ScarWork therapy (up to five individualised ScarWork sessions)
The ScarWork treatment will be tailored to each participant's needs, in keeping with typical clinical practice. Outcome measures will be collected at the beginning of the study, after the final ScarWork session, and again four weeks after the treatment ends. This will help the research team assess both immediate and longer-term effects of the therapy.
Participants will complete questionnaires about their pain, scar-related symptoms, and general wellbeing. They will be able to complete these online, by post, or over the phone with a researcher. Those in the ScarWork group may also be invited to take part in a short interview to share their experiences of the treatment and the study process.
The findings will help researchers decide whether a larger, more detailed clinical trial is possible and worthwhile in the future.
Importance of study Pain after breast cancer treatment is common but under-recognised and under-treated. This study addresses an important gap in care by exploring a therapy that could provide relief to thousands of people living with post-treatment pain. By assessing ScarWork in a structured NHS setting, the study also helps build evidence for how complementary therapies can be integrated into cancer aftercare in a safe and measured way.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will employ a pragmatic mixed methods randomised parallel-group exploratory design.
| Arm | Type | Receives |
|---|---|---|
| ScarWork plus standard care | Active comparator | Other: ScarWork therapyParticipant received up to 5 ScarWork sessions alongside usual standard of care |
| Standard care | No intervention | –Participants continue with their usual standard of care and symptom management without additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over the age of 18
- Early breast cancer patients who have had breast surgery with curative intent
- Radiotherapy completed ≥ 6 months previously
- In remission with no sign of active local disease
- Registering a score of ≥3 on perceived pain intensity or pain burden on a 10-point numerical rating scale (NRS)
Key exclusion criteria (6 listed)
- History of post-breast surgery wound complications
- History of breast surgery unrelated to breast cancer treatment
- History of previous ScarWork therapy
- Diagnosis of lymphoedema
- Severe co-morbidities or cognitive disability
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 |
|---|---|---|
| ScarWork therapyScarWork is a manual therapy technique involving gentle, hands-on massage of scar tissue. It is designed to improve the mobility and integration of scar tissue, reduce discomfort, and support tissue healing. The approach is tailored to each individual, based on the characteristics of their scar and sensitivity of the surrounding tissue. It is commonly used with people recovering from surgery or radiotherapy to help address symptoms such as pain, tightness, numbness, or altered sensation. In this study, participants in the intervention group will receive up to five ScarWork sessions delivered by a trained therapist, in addition to standard care. | Other | ScarWork plus standard care |
Primary outcome
BREAST-Q Breast Conserving Therapy Module V2.0
Time frame: Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).
A validated patient-reported outcome measure designed to evaluate outcomes among women undergoing breast conserving therapy, with the two overarching domains of 1) health-related quality of life and 2) patient satisfaction. Scales can be used selectively as appropriate to the research. For this study, we will measure: 1. Quality of life domains using: * Psychosocial Well-being scale comprises 10 items that ask about body image and a woman's confidence in social settings, as well as emotional health and self esteem. * Sexual Well-being scale comprises 6 items that ask about feelings of sexual attractiveness and confidence relating to breasts. * Physical Well-being * Chest scale comprises 9 items measuring problems in the breast area (tightness, pulling, tenderness, pain), activity limitations and sleep problems due to discomfort. * Adverse Effects of Radiation scale 2. Satisfaction with Breasts
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 3 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality, as the dataset includes sensitive health information related to scar treatment outcomes. Aggregate or de-identified data may be available on request.
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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.
Royal London Hospital for Integrated Medicine
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ScarWork therapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by University College London Hospitals at 1 site in United Kingdom.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BREAST-Q Breast Conserving Therapy Module V2.0 (time frame: Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).). 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 3 Oct 2025.