Breast CancerNCT02702050
Effect of Mechanical Stimulation on Mastectomy Scars
A study testing Mechanical stimulation (LPG system; Cellu M6 Integral I) and Conventional treatment in people with Breast Cancer, run by The Queen Elizabeth Hospital at 1 site in Hong Kong.
Trial summary
The purpose of this study is to investigate the efficacy of mechanical stimulation on mastectomy scars in: (i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mechanical stimulation (LPG system; Cellu M6 Integral I) and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2016to 29 Mar 2018
- 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
- Women aged 18 years old or above with mastectomy performed in recent 6 weeks;
- Able to attend physiotherapy treatment and follow-ups during the study period.
Who cannot join
- Altered mental state for cooperation and informed consent;
- Signs and symptoms of mastectomy scar infections or inflammations;
- Unhealed mastectomy wounds;
- History of lymphoedema;
- Diagnosed bilateral breast cancers;
- Unstable medical or cardiovascular conditions;
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- Pre-existing arm impairments/dysfunctions that will affect testing or exercising the affected arm;
- Receiving radiotherapy during the study period;
- Known sensitivity to mechanical stimulation;
- Skin cancer on the treatment area;
- Unclear cut margins of the cancer;
- Known metastasis to other areas;
- HIV positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Clinical Trial to Investigate the Effect of Mechanical Stimulation on Mastectomy Scars
The purpose of this study is to investigate the efficacy of mechanical stimulation on mastectomy scars in:
(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
Read the detailed description
Background:
Breast cancer is common among women. After surgical interventions like mastectomies, women with breast cancer may suffer physical, emotional and psychosocial complications. Evidence suggests that comprehensive physiotherapy program, including patient education, manual techniques, therapeutic exercises and compression bandaging, is effective in managing the above complications. Scarring was frequently overlooked in past studies. Besides cosmetic issues, a post mastectomy scar may cause adverse physical, functional, and psychological outcomes. The effects of mechanical stimulation on mastectomy scars have not been well investigated yet.
Objectives:
To investigate the efficacy of mechanical stimulation in:
(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
Setting:
Out-patient physiotherapy breast care clinic at the Hong Kong Queen Elizabeth Hospital
Participants:
One hundred and eight women with breast cancer after mastectomy in recent 6 weeks will be recruited.
Methodology:
An assessor-blind, randomized controlled trial will be conducted. 108 women with breast cancer after mastectomy will be recruited from the breast care clinic of the Queen Elizabeth Hospital. They will be randomly allocated by block randomization method into either the mechanical stimulation group (n= 54) or conventional treatment group (n=54).
Both study groups will receive an educational session before commencement of the program. Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises will be provided within a 6-week period (i.e., two sessions per week) to all subjects. For the mechanical stimulation group, a ten-minute mechanical stimulation program will be provided. For the conventional treatment group, no mechanical stimulation will be given.
Primary outcomes include scar evaluations by the Vancouver Scar Scale and spectrophotometry. Secondary outcomes are composite measurements of shoulder morbidities, including numeric pain rating scale (NPS), shoulder range of movement and hand grip strength; arm function as evaluated by the Disabilities of the Arm, Shoulder and Hand (DASH-HKPWH) questionnaire; and quality of life as measured by the Functional Assessment of Chronic Illness Therapy - Breast Cancer (FACT-B). Outcome assessments at baseline, immediately after the 6-week program, and 3-month follow-up periods will be conducted by blinded assessors at the breast care clinic.
Data Analysis:
The results will be analyzed using two-way repeated measures analysis of variance with Statistical Package for Social Sciences version 21.0. Alpha level will be set at 0.05.
Potential Clinical Significance of Study:
Improvement of physiotherapy in scar management might potentially improve scar appearance - pigmentation, vascularity, pliability and thickness, decrease shoulder morbidities, improve upper limb functions, and enhance quality of life for women with breast cancer after mastectomy. If the mechanical stimulation protocol is proven to be effective, it will bring about significant advances in physiotherapy practice in post-mastectomy care in an evidence-based manner.
- Conditions
- Breast Cancer
- Being tested
- Mechanical stimulation (LPG system; Cellu M6 Integral I), Conventional treatment
- Keywords
- Physiotherapy, Mechanical Stimulation, Mastectomy Scar
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical stimulation (LPG system; Cellu M6 Integral I)Other
Also called Therapeutic massager
For the mechanical stimulation group, an additional ten-minute mechanical stimulation will be provided in each of the twelve sessions of convention treatment program. The device produced skin lift through suction via a treatment head with 2 rollers installed. It was a non-invasive technique which aimed to mobilize soft tissues by creating skin folds and stretching the underlying soft tissues while manipulating the treatment head according to protocol.
Conventional treatmentOther
Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises, within a 6-week period (i.e., two sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Active comparator | Conventional treatment group will receive an educational session before commencement of the program. Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises will be provided within a 6-week period (i.e., two sessions per week) to all subjects. No mechanical stimulation will be given. Receives: Other: Conventional treatment |
| Mechanical stimulation group | Experimental | A 10 minute mechanical stimulation program - 'Mechanical stimulation (LPG system; Cellu M6 Integral I), will be provided after each of the twelve sessions of conventional treatment. Receives: Other: Mechanical stimulation (LPG system; Cellu M6 Integral I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scare Scale (VSS) to study scar appearance
A scar scale to quantify scar appearance by observing the thickness, pliability, pigmentation and vascularity of mastectomy scar. The former two items were rated on ordical scales whereas the later two items in a descriptive manner. Total score ranged from 0 to 13.
Measured: 6 months
Spectrophotometry to measure scar color
A spectrophotometer (Hunterlab Miniscan Ez4500S, USA) is used to measure level of lightness, redness and yellowness of the mastectomy scar versus adjacent normal skin. Level of redness indicated vascularization and pigmentation represented significance of melanin deposited in a scar.
Measured: 6 months
Secondary outcomes (5)
Numeric pain rating scale (NPS) to study pain over affected breast
11-item numeric rating scale (NRS) is valid, reliable and appropriate for use in clinical setting for pain measurement
Measured: 6 months
Shoulder range by goniometry
Shoulder range of motion (ROM) will be evaluated by measuring active shoulder flexion and abduction
Measured: 6 months
Grip strength by hand-held dynamometer
The hand grip strength will be evaluated using the JAMAR Hydraulic Hand Dynamometer
Measured: 6 months
Arm function
The Chinese version of the Disabilities of the Arm, Shoulder and Hand (DASH-HKPWH) questionnaire will be used as an outcome measurement for upper extremities disabilities and symptoms.
Measured: 6 months
Quality of life
The Functional Assessment of Chronic Illness Therapy - Breast Cancer (FACT-B), traditional Chinese version 4 questionnaire would be adopted for measurement of quality of life for women with breast cancer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka Po Andrea LEUNG, The Queen Elizabeth Hospital
- Investigators
- Andrea KP LEUNG, MSc, Principal investigator, Physiotherapy Department ,Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702050
- Sponsor's protocol ID
- KC/KE-15-0816/FR-3
- Status last verified
- Apr 2018
- First submitted
- 26 Feb 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial to Investigate the Effect of Mechanical Stimulation on Mastectomy Scars
- ClinicalTrials.gov ID
- NCT02702050
- Acronym / sponsor ID
- KC/KE-15-0816/FR-3
- Conditions
- Breast Cancer
- Keywords
- Physiotherapy, Mechanical Stimulation, Mastectomy Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 8 Mar 2016 (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.
The purpose of this study is to investigate the efficacy of mechanical stimulation on mastectomy scars in:
(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
Detailed description
Background:
Breast cancer is common among women. After surgical interventions like mastectomies, women with breast cancer may suffer physical, emotional and psychosocial complications. Evidence suggests that comprehensive physiotherapy program, including patient education, manual techniques, therapeutic exercises and compression bandaging, is effective in managing the above complications. Scarring was frequently overlooked in past studies. Besides cosmetic issues, a post mastectomy scar may cause adverse physical, functional, and psychological outcomes. The effects of mechanical stimulation on mastectomy scars have not been well investigated yet.
Objectives:
To investigate the efficacy of mechanical stimulation in:
(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
Setting:
Out-patient physiotherapy breast care clinic at the Hong Kong Queen Elizabeth Hospital
Participants:
One hundred and eight women with breast cancer after mastectomy in recent 6 weeks will be recruited.
Methodology:
An assessor-blind, randomized controlled trial will be conducted. 108 women with breast cancer after mastectomy will be recruited from the breast care clinic of the Queen Elizabeth Hospital. They will be randomly allocated by block randomization method into either the mechanical stimulation group (n= 54) or conventional treatment group (n=54).
Both study groups will receive an educational session before commencement of the program. Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises will be provided within a 6-week period (i.e., two sessions per week) to all subjects. For the mechanical stimulation group, a ten-minute mechanical stimulation program will be provided. For the conventional treatment group, no mechanical stimulation will be given.
Primary outcomes include scar evaluations by the Vancouver Scar Scale and spectrophotometry. Secondary outcomes are composite measurements of shoulder morbidities, including numeric pain rating scale (NPS), shoulder range of movement and hand grip strength; arm function as evaluated by the Disabilities of the Arm, Shoulder and Hand (DASH-HKPWH) questionnaire; and quality of life as measured by the Functional Assessment of Chronic Illness Therapy - Breast Cancer (FACT-B). Outcome assessments at baseline, immediately after the 6-week program, and 3-month follow-up periods will be conducted by blinded assessors at the breast care clinic.
Data Analysis:
The results will be analyzed using two-way repeated measures analysis of variance with Statistical Package for Social Sciences version 21.0. Alpha level will be set at 0.05.
Potential Clinical Significance of Study:
Improvement of physiotherapy in scar management might potentially improve scar appearance - pigmentation, vascularity, pliability and thickness, decrease shoulder morbidities, improve upper limb functions, and enhance quality of life for women with breast cancer after mastectomy. If the mechanical stimulation protocol is proven to be effective, it will bring about significant advances in physiotherapy practice in post-mastectomy care in an evidence-based manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Active comparator | Other: Conventional treatmentConventional treatment group will receive an educational session before commencement of the program. Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises will be provided within a 6-week period (i.e., two sessions per week) to all subjects. No mechanical stimulation will be given. |
| Mechanical stimulation group | Experimental | Other: Mechanical stimulation (LPG system; Cellu M6 Integral I)A 10 minute mechanical stimulation program - 'Mechanical stimulation (LPG system; Cellu M6 Integral I), will be provided after each of the twelve sessions of conventional treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 years old or above with mastectomy performed in recent 6 weeks;
- Able to attend physiotherapy treatment and follow-ups during the study period.
Key exclusion criteria (13 listed)
- Altered mental state for cooperation and informed consent;
- Signs and symptoms of mastectomy scar infections or inflammations;
- Unhealed mastectomy wounds;
- History of lymphoedema;
- Diagnosed bilateral breast cancers;
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 |
|---|---|---|
| Mechanical stimulation (LPG system; Cellu M6 Integral I)Also: Therapeutic massagerFor the mechanical stimulation group, an additional ten-minute mechanical stimulation will be provided in each of the twelve sessions of convention treatment program. The device produced skin lift through suction via a treatment head with 2 rollers installed. It was a non-invasive technique which aimed to mobilize soft tissues by creating skin folds and stretching the underlying soft tissues while manipulating the treatment head according to protocol. | Other | Mechanical stimulation group |
| Conventional treatmentTwelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises, within a 6-week period (i.e., two sessions per week) | Other | Conventional treatment group |
Primary outcome
Vancouver Scare Scale (VSS) to study scar appearance
Time frame: 6 months
A scar scale to quantify scar appearance by observing the thickness, pliability, pigmentation and vascularity of mastectomy scar. The former two items were rated on ordical scales whereas the later two items in a descriptive manner. Total score ranged from 0 to 13.
Spectrophotometry to measure scar color
Time frame: 6 months
A spectrophotometer (Hunterlab Miniscan Ez4500S, USA) is used to measure level of lightness, redness and yellowness of the mastectomy scar versus adjacent normal skin. Level of redness indicated vascularization and pigmentation represented significance of melanin deposited in a scar.
5 secondary outcomes
Numeric pain rating scale (NPS) to study pain over affected breast
Time frame: 6 months
Shoulder range by goniometry
Time frame: 6 months
Grip strength by hand-held dynamometer
Time frame: 6 months
Arm function
Time frame: 6 months
Quality of life
Time frame: 6 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 5 Apr 2018.
- Individual participant dataSharing planned: No
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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 KP LEUNG, MSc principal investigator
Physiotherapy Department ,Queen Elizabeth 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 Mechanical stimulation (LPG system; Cellu M6 Integral I) and Conventional treatment in people with Breast Cancer, run by The Queen Elizabeth Hospital at 1 site in Hong Kong.
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 2 inclusion and 13 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 5 Apr 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 Hong Kong. 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 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?
Vancouver Scare Scale (VSS) to study scar appearance (time frame: 6 months). The study lists 2 primary outcomes in all. 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 5 Apr 2018.