Breast CancerPhase 3NCT00175344
Does Scar Massage Improve Postoperative Pain and Function in Women With Breast Cancer?
A Phase 3 study testing Scar massage. in people with Breast Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
All patients undergoing breast cancer surgery are left with scars which can significantly affect their physical and psychological well being. Patients with breast cancer, motivated to optimize healing and function, have inquired about the advisability of scar massage after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Scar massage.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2004to Apr 2006
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to provide informed consent and be physically able to perform daily self-administered breast scar massage
- Female or male patients with histologically-confirmed invasive or in situ breast cancer
- Definitive surgery with BCS or mastectomy +/- axillary dissection or sentinel node sampling
- Adequate surgical healing as judged by treating oncologist during pre-enrolment assessment
- Age 18 years or older with ability to provide written informed consent.
- Ability to start massage within 8 weeks from surgery and comply with daily regimen if randomized to the intervention cohort
- Ability to comply with not performing massage if randomized to the control cohort
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, V8R 6V5
About this study
Official title: Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.
All patients undergoing breast cancer surgery are left with scars which can significantly affect their physical and psychological well being. Patients with breast cancer, motivated to optimize healing and function, have inquired about the advisability of scar massage after surgery. Although this is a popular technique advocated by physiotherapists and massage therapists to improve pain, range of motion, and scar pliability, there is currently no scientific research to prove the benefits and/or risks of scar massage in breast cancer patients. We propose to study the effect of scar massage on pain, arm function, scar formation, and quality of life in patients with breast cancer. Patients who have had breast cancer surgery and who have been referred to the BC Cancer Agency, Vancouver Island Centre will be offered participation in this research study. To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars. In both groups, we will monitor pain, upper body range of motion, scar characteristics and quality of life using standardized criteria for 2 years from the time of surgery. Problems with infections or blood or fluid accumulation at the scar areas will also be monitored. After 2 years, the information collected will be analyzed and compared to see if there are differences in pain, function or quality of life between the two groups. The results from this study will provide scientific proof of whether or not scar massage after surgery is beneficial for patients with breast cancer.
Read the detailed description
This is a prospective randomized controlled trial design. Women who have undergone breast cancer surgery (breast conserving surgery or mastectomy) and who meet the eligibility criteria specified will be offered study participation. After obtaining informed consent, subjects will be randomized between two cohorts: scar massage (intervention group) versus no scar massage (control group). The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form). The secondary outcomes are: upper body range of motion, physical parameters of the scar (pliability, scar height, vascularity and pigmentation scored using the Vancouver Scar Scale), lymphedema (evaluated by arm circumference measurements) and quality of life (using the Functional Assessment of Cancer Therapy (FACT)-B breast cancer-specific instrument).
A sample size of 143 patients per arm was estimated to detect a 30% difference in the primary outcome of postoperative scar-related pain between the intervention and the control groups with 80% statistical power.
- Conditions
- Breast Cancer
- Being tested
- Scar massage.
- Keywords
- Breast cancer, scar massage, breast conserving surgery, scar pain, quality of life, Breast cancer treated with breast conserving surgery with or without axillary dissection or sentinel node sampling.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar massage.Procedure or surgery
To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Arm A: Self-administered massage of the postoperative scar after breast cancer surgery. Receives: Procedure: Scar massage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).
Measured: Two years
Secondary outcomes (1)
The secondary outcomes are: upper body range of motion, physical parameters of the scar (pliability, scar height, vascularity and pigmentation scored using the Vancouver Scar Scale), lymphedema (evaluated by arm circumference measurements) and quality of
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Truong, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175344
- Sponsor's protocol ID
- H03-60011
- Status last verified
- Feb 2014
- First submitted
- 11 Sep 2005
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT00175344
- Acronym / sponsor ID
- H03-60011
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, scar massage, breast conserving surgery, scar pain, quality of life, Breast cancer treated with breast conserving surgery with or without axillary dissection or sentinel node sampling.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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.
All patients undergoing breast cancer surgery are left with scars which can significantly affect their physical and psychological well being. Patients with breast cancer, motivated to optimize healing and function, have inquired about the advisability of scar massage after surgery. Although this is a popular technique advocated by physiotherapists and massage therapists to improve pain, range of motion, and scar pliability, there is currently no scientific research to prove the benefits and/or risks of scar massage in breast cancer patients. We propose to study the effect of scar massage on pain, arm function, scar formation, and quality of life in patients with breast cancer. Patients who have had breast cancer surgery and who have been referred to the BC Cancer Agency, Vancouver Island Centre will be offered participation in this research study. To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars. In both groups, we will monitor pain, upper body range of motion, scar characteristics and quality of life using standardized criteria for 2 years from the time of surgery. Problems with infections or blood or fluid accumulation at the scar areas will also be monitored. After 2 years, the information collected will be analyzed and compared to see if there are differences in pain, function or quality of life between the two groups. The results from this study will provide scientific proof of whether or not scar massage after surgery is beneficial for patients with breast cancer.
Detailed description
This is a prospective randomized controlled trial design. Women who have undergone breast cancer surgery (breast conserving surgery or mastectomy) and who meet the eligibility criteria specified will be offered study participation. After obtaining informed consent, subjects will be randomized between two cohorts: scar massage (intervention group) versus no scar massage (control group). The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form). The secondary outcomes are: upper body range of motion, physical parameters of the scar (pliability, scar height, vascularity and pigmentation scored using the Vancouver Scar Scale), lymphedema (evaluated by arm circumference measurements) and quality of life (using the Functional Assessment of Cancer Therapy (FACT)-B breast cancer-specific instrument).
A sample size of 143 patients per arm was estimated to detect a 30% difference in the primary outcome of postoperative scar-related pain between the intervention and the control groups with 80% statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Scar massage.Arm A: Self-administered massage of the postoperative scar after breast cancer surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be able to provide informed consent and be physically able to perform daily self-administered breast scar massage
- Female or male patients with histologically-confirmed invasive or in situ breast cancer
- Definitive surgery with BCS or mastectomy +/- axillary dissection or sentinel node sampling
- Adequate surgical healing as judged by treating oncologist during pre-enrolment assessment
- Age 18 years or older with ability to provide written informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Scar massage.To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars. | Procedure or surgery | A |
Primary outcome
The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).
Time frame: Two years
1 secondary outcome
The secondary outcomes are: upper body range of motion, physical parameters of the scar (pliability, scar height, vascularity and pigmentation scored using the Vancouver Scar Scale), lymphedema (evaluated by arm circumference measurements) and quality of
Time frame: Two years
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 19 Feb 2014.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Pauline Truong, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Scar massage. in people with Breast Cancer, run by University of British Columbia at 1 site in Canada.
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 7 inclusion and 0 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 19 Feb 2014. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form). (time frame: Two years). 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 19 Feb 2014.