Breast NeoplasmsPhase 4BotoxNCT01427400
The Use of Botulinum Toxin A in Two-Stage Tissue Expander/ Implant Breast Reconstruction
A Phase 4 study testing Botulinum Toxin-A and Saline in people with Breast Neoplasms and Neoplasms by Site, run by University of British Columbia at 2 sites in Canada.
Trial summary
Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these breast reconstructions, 65% use a tissue expander/implant technique. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasms by Site, Neoplasms
- What is being tested?
- Botulinum Toxin-A and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2011to Dec 2017
- Phase
- Phase 4
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo immediate, post-mastectomy, unilateral or bilateral, tissue expander/implant reconstruction
- Patients older than 21, with no upper age limit
- English-speaking, or has an appropriate translator
Who cannot join
- Patient declines inclusion in the study
- Patients who undergo a single-stage implant reconstruction or combined autogenous tissue expander/implant reconstruction
- Previous history of radiation
- Previous breast surgery with implants
- Previous history of axillary lymph node dissection
- Patients who are pregnant
Show all 9Show fewer
- Patients with hepatorenal failure
- Patients with known hypersensitivity to Botulinum Toxin-A
- Patients with significant mastectomy flap ischemia at time of tissue expander placement
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Plastic, Reconstructive and Cosmetic Surgery
Surrey, British Columbia, V3V 1N1
Adrian Lee, MD, FRCSC
Paul Oxley, MD, FRCSC
- Recruiting
Canada, British Columbia
Vancouver, British Columbia, V5Z 1M9
Adelyn L Ho, MD MPH, 604-773-5466, adelynh@interchange.ubc.ca
Joline T Choi, MBBS MHS, 604-875-4111 ext. 68489, joline.choi@vch.ca
About this study
Official title: The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial
Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory results can be achieved with a single-stage technique, a two-stage approach is considered more reliable, allowing for precise positioning of the inframammary fold and an opportune time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue.
The placement of the tissue expander and implant under the chest muscles is thought to minimize the incidence of capsular contracture, expander exposure, and in addition, produce acceptable aesthetic results. However, discomfort is often associated with this submuscular placement of a tissue expander or implant, specifically during the expansion phase. Patients undergoing immediate reconstruction using submuscular implants have been shown to have higher analgesic requirements and to have higher pain scores post-operatively, compared to non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the expander, a longer expansion process, abandonment of reconstruction, and a compromised quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at the time of surgery may help ease the discomfort that is often associated with this procedure.
The investigators propose a prospective double-blind randomized placebo-controlled trial of patients undergoing tissue expander/implant reconstruction. The information gathered from this analysis will provide a greater understanding of the effects of Botox in the setting of two-stage tissue expander/implant breast reconstruction, with the goal to improve patient satisfaction and quality of life.
Read the detailed description
Currently, there is level C evidence for the efficacy of Botox in the treatment of postoperative pain and muscle spasms in breast reconstruction patients. Additional high-level evidence is necessary to justify the use of Botox in breast cancer patients, which potentially will improve the reconstructive process for these patients and improve quality of life. Additionally, there have been no studies to date that have evaluated patient satisfaction and QOL in this setting. The investigators will evaluate patient satisfaction and QOL using the Breast-Q© during different time periods after two-stage tissue expander/implant reconstruction. Previous studies have demonstrated a reduction in pain when Botox was used during tissue expander/implant breast reconstruction, however, these studies were not blinded which may introduce bias. Additionally, a timely reconstruction is important to the patient, and a decrease in pain may result in a shorter fill interval and an increased total amount of volume in the tissue expander. The investigators will therefore document both the amount of expansion that a patient can tolerate at each follow-up visit and the total volume expanded, and compare the data between the Botox group to the group assigned to placebo.
- Conditions
- Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
- Being tested
- Botulinum Toxin-A, Saline
- Keywords
- Breast expander, Breast reconstruction, Implants, Botox
- Medical subject headings
- Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin-ADrug
Also called Botulinum Toxin Type A
100 Units diluted in 25cc saline
SalineDrug
Also called 0.9% Sodium Chloride
Dispensed in a 25cc syringe
| Study group | Role | What they receive |
|---|---|---|
| Expander Placement, Botulinum Toxin-A | Experimental | During surgery, administered only once, 5 cc in 5 different locations on chest muscle. Receives: Drug: Botulinum Toxin-A |
| Tissue expander Placement WITH Saline | Placebo comparator | During surgery, administered only once, 5 cc in 5 different locations on chest muscle. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Quality of life and patient satisfaction using the Breast-Q
The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care.
Measured: Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op
Secondary outcomes (2)
Patient-reported pain,using the BPI (Brief Pain Inventory) and Pain Diary during the expansion phase (initial to final expansion) and in the long-term period (6 and 12 months).
The BPI is a common patient-reported instrument used to assess clinical pain. The BPI assesses the severity of pain and the impact of pain on daily functions in patients with pain from chronic diseases or conditions or acute conditions (i.e. postoperative pain).
The question asked on the daily pain diary will be derived from the BPI: "Every evening at the same time, please rate the worst pain you've experienced in the last 24 hours when 0 represents no pain and 10 represents the most severe pain imaginable".
Measured: BPI (before 1st surgery, day of surgery, 2 weeks, ~ 6 - 8 weeks, before 2nd surgery, 6 months and 12 months). After 1st surgery, pain diary is to be filled out every evening at the same time.
Aesthetic outcome
Aesthetic results can be evaluated using different methods: patient-reported aesthetic satisfaction (Breast-Q) and aesthetic outcome from the perspective of the health professional. Standardized photographs using a three-category, five-item Breast Aesthetic Score. This scoring scheme separates the various components of the aesthetic results of the breast into different subscale thus allowing the rating to be more explicit. This score has not been validated, but has demonstrated good inter- and intra-rater reliability.
Measured: 6 months and 12 months (after 2nd surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health, Providence Health & Services, Fraser Health
- Responsible party
- Sponsor
- Investigators
- Adelyn Ho, MD, MPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427400
- Sponsor's protocol ID
- H10-03166
- Acronym
- Botox
- Status last verified
- Jul 2016
- First submitted
- 18 Aug 2011
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01427400
- Acronym / sponsor ID
- Botox / H10-03166
- Conditions
- Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
- Keywords
- Breast expander, Breast reconstruction, Implants, Botox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health, Providence Health & Services, Fraser Health
- Study start
- Oct 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Sep 2011 (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.
Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory results can be achieved with a single-stage technique, a two-stage approach is considered more reliable, allowing for precise positioning of the inframammary fold and an opportune time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue.
The placement of the tissue expander and implant under the chest muscles is thought to minimize the incidence of capsular contracture, expander exposure, and in addition, produce acceptable aesthetic results. However, discomfort is often associated with this submuscular placement of a tissue expander or implant, specifically during the expansion phase. Patients undergoing immediate reconstruction using submuscular implants have been shown to have higher analgesic requirements and to have higher pain scores post-operatively, compared to non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the expander, a longer expansion process, abandonment of reconstruction, and a compromised quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at the time of surgery may help ease the discomfort that is often associated with this procedure.
The investigators propose a prospective double-blind randomized placebo-controlled trial of patients undergoing tissue expander/implant reconstruction. The information gathered from this analysis will provide a greater understanding of the effects of Botox in the setting of two-stage tissue expander/implant breast reconstruction, with the goal to improve patient satisfaction and quality of life.
Detailed description
Currently, there is level C evidence for the efficacy of Botox in the treatment of postoperative pain and muscle spasms in breast reconstruction patients. Additional high-level evidence is necessary to justify the use of Botox in breast cancer patients, which potentially will improve the reconstructive process for these patients and improve quality of life. Additionally, there have been no studies to date that have evaluated patient satisfaction and QOL in this setting. The investigators will evaluate patient satisfaction and QOL using the Breast-Q© during different time periods after two-stage tissue expander/implant reconstruction. Previous studies have demonstrated a reduction in pain when Botox was used during tissue expander/implant breast reconstruction, however, these studies were not blinded which may introduce bias. Additionally, a timely reconstruction is important to the patient, and a decrease in pain may result in a shorter fill interval and an increased total amount of volume in the tissue expander. The investigators will therefore document both the amount of expansion that a patient can tolerate at each follow-up visit and the total volume expanded, and compare the data between the Botox group to the group assigned to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expander Placement, Botulinum Toxin-A | Experimental | Drug: Botulinum Toxin-ADuring surgery, administered only once, 5 cc in 5 different locations on chest muscle. |
| Tissue expander Placement WITH Saline | Placebo comparator | Drug: SalineDuring surgery, administered only once, 5 cc in 5 different locations on chest muscle. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergo immediate, post-mastectomy, unilateral or bilateral, tissue expander/implant reconstruction
- Patients older than 21, with no upper age limit
- English-speaking, or has an appropriate translator
Key exclusion criteria (9 listed)
- Patient declines inclusion in the study
- Patients who undergo a single-stage implant reconstruction or combined autogenous tissue expander/implant reconstruction
- Previous history of radiation
- Previous breast surgery with implants
- Previous history of axillary lymph node dissection
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 |
|---|---|---|
| Botulinum Toxin-AAlso: Botulinum Toxin Type A100 Units diluted in 25cc saline | Drug | Expander Placement, Botulinum Toxin-A |
| SalineAlso: 0.9% Sodium ChlorideDispensed in a 25cc syringe | Drug | Tissue expander Placement WITH Saline |
Primary outcome
Change from Baseline in Quality of life and patient satisfaction using the Breast-Q
Time frame: Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op
The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care.
2 secondary outcomes
Patient-reported pain,using the BPI (Brief Pain Inventory) and Pain Diary during the expansion phase (initial to final expansion) and in the long-term period (6 and 12 months).
Time frame: BPI (before 1st surgery, day of surgery, 2 weeks, ~ 6 - 8 weeks, before 2nd surgery, 6 months and 12 months). After 1st surgery, pain diary is to be filled out every evening at the same time.
Aesthetic outcome
Time frame: 6 months and 12 months (after 2nd surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- UBC Division of Plastic SurgeryLink provided by the sponsor.
- Canadian Breast Cancer FoundationLink provided by the sponsor.
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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.
Adelyn Ho, MD, MPH principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin-A and Saline in people with Breast Neoplasms and Neoplasms by Site, run by University of British Columbia at 2 sites 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adelyn L Ho, MD MPH (604-773-5466, adelynh@interchange.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Quality of life and patient satisfaction using the Breast-Q (time frame: Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op). 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 29 Jul 2016.