Breast CancerAcuPOPNCT03655600
Acupressure for Pain and Opioid Use Among Breast Cancer Patients
A study testing Self-administered acupressure in people with Breast Cancer and Fatigue, run by University of Michigan at 1 site in United States.
Trial summary
This study seeks to determine the feasibility of recruiting and training participants in self-acupressure, for women undergoing primary breast cancer surgery or delayed reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue, Chronic Pain
- What is being tested?
- Self-administered acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 17 Oct 2019
- 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
- Diagnosis of breast cancer stage 0 to III;
- Planned unilateral or bilateral mastectomy or planned delayed breast reconstruction surgery within 24 months following unilateral or bilateral mastectomy;
- For delayed breast reconstruction patients only: apparently cancer free at time of delayed reconstruction;
- No planned new interventions for pain the two weeks prior to surgery;
- Able to self-administer treatment at the specified points.
Who cannot join
- Medically unstable (e.g. uncontrolled diabetes, high blood pressure, etc.);
- For delayed breast reconstruction only: taking aromatase inhibitors which could confound surgical and chronic pain measurements;
- Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder;
- Unwilling to maintain stable does of allowed chronic pain medications (e.g. NSAIDS, benzodiazepines, SSRIs and SNRIs);
- Pregnant, those planning a pregnancy, or lactating mothers;
- Any medical condition or treatment factor that the study team feels would either compromise the data acquired or introduce a potential safety concern.
- Unable to give consent;
- Acupuncture or acupressure receipt in past year
Trial locations and contacts
1 site in 1 country.
United States1 site
Chronic Pain and Fatigue Research Center, University of Michigan
Ann Arbor, Michigan, 48105
About this study
Official title: Acupressure for Preventing Post-Operative Pain and Opioid Use Among Breast Cancer Patients Receiving Surgery
This study seeks to determine the feasibility of recruiting and training participants in self-acupressure, for women undergoing primary breast cancer surgery or delayed reconstruction surgery. The study seeks to determine also if self-acupressure is effective in reducing the need for opioids post-surgery and the effects on other life factors.
Read the detailed description
Chronic pain following breast cancer surgery is a significant problem for women. There are over 3 million women in the United States living as breast cancer survivors. Sustained post-surgical pain is one of the most troubling side-effects for these women and continues to affect around 25-60% of breast cancer survivors, with approximately half classifying pain as being moderate to severe. Chronic cancer-related pain is associated with increased fatigue, depression, anxiety, sleep disruption, and decreased quality of life and function.
Acute pre- and post-operative pain are significant predictors of sustained pain following breast cancer surgery, but are insufficiently managed. The etiology of persistent breast cancer related pain following surgery is multifactorial and may be the direct effect of cancer or cancer treatment (e.g. surgery). Known risk factors for this chronic pain include younger age, higher body mass index, type of surgery (axillary lymph node dissection), and presence of a mood disturbance. Cancer patients may develop pain from neurotoxicity from adjuvant chemotherapy, and radiation may also play a role, and causes persistent pain in 13 - 26% of patients.
Two of the most significant factors that determine persistent pain following breast cancer surgery are the degree of pre-surgical pain and acute post-surgical pain. Recent reports have suggested that treatments aimed at reducing these factors may be effective at preventing the development of chronic pain following breast cancer surgery. Existing pre-emptive treatments to reduce this acute surgical pain include the use of nerve blocks and/or pharmacologic agents such as opioids, NSAIDs, ketamine, and gabapentin. While some pharmacologic approaches yield clinically meaningful reductions in post-operative pain in the research setting, there remains controversy in the field. For example in breast surgery specifically, a recent meta-analysis showed that thoracic paravertebral blocks have a statistically significant effect on reducing chronic pain, but the effect was not clinically meaningful and was associated with procedural risks such as vascular puncture.
In addition to the risk of developing pain following breast cancer surgery, women also report increased acute and chronic surgical pain following breast reconstruction surgery. In one of the first studies to examine pain post-reconstruction surgery, Wallace et al. found that the incidence of pain one year following breast cancer mastectomy plus reconstruction was 49% as compared to 31% for mastectomy alone. This increase was both statistically and clinically significant, and remains a current undertreated problem. Overall many women develop persistent pain after breast cancer surgery following either tumor removal or breast reconstruction. We know that this is influenced by acute pre- and post-surgical pain, but unfortunately the existing measures available for clinicians to prevent persistent post-surgical pain are not adequate.
Opioids are commonly used analgesics in the perioperative surgical setting; however, they are accompanied by significant limitations. Opioids are the most common pharmacologic intervention used for acute perioperative surgical pain. They are known to decrease pain via activation of specific receptors (mu, delta, and kappa), which inhibit neuronal firing resulting in reduced nociceptive activity. Although widely prescribed there are significant limitations for opioid use including tolerance, addiction, diversion, and even mortality. There were over 33,000 opioid deaths in the US in 2016 alone and the majority of these have been from opioid prescriptions. The US is currently experiencing an opioid epidemic wherein Americans constitute only 5% of the global population yet we consume over 80% of the world's opioid supply. Unfortunately, while opioids are needed in the surgical setting, the problem of increased opioid use is itself compounded by surgery. Patients receiving even low-risk surgeries are 44% more likely to become de novo long-term opioid consumers. With respect to breast cancer surgery, the odds of developing chronic opioid consumption following mastectomy increases by approximately 300%. Although the reason(s) for developing chronic opioid consumption are largely unknown, patients that receive a new opioid prescription within 7 days post-surgery, as compared to those who do not, are more likely to still be receiving opioids one year out. Thus acute pre-surgical and post-surgical pain, in addition to being risk factors for persistent chronic pain, may also increase the probability of becoming a chronic opioid consumer. There is an unmet need for analgesic interventions that are opioid sparing in the breast cancer surgical setting. This study proposes that acupressure may be one such option.
Acupressure Self-administered acupressure is one possible safe, self-management technique which may be effective for improving post-operative pain and opioid consumption. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease. Prior research has demonstrated that acupressure, self-administered by women with breast cancer, significantly reduced clinically significant pain by approximately one-third and was superior to standard therapies. Moreover, these self-rated improvements were maintained up to one month after treatment was discontinued.
Acupressure has been found to be effective for acute post-surgical pain, but no studies have examined the impact on the development of chronic pain or acute and chronic opioid use in any patient population. Four previous studies in diverse patient populations (appendectomy, cesarean section, gastric cancer, and knee arthroscopy) have found that acupressure delivered by an acupressure practitioner was able to significantly decrease post-surgical pain compared to either usual care or sham acupressure from as early as 60 minutes after surgery to as long as 3 days post-surgery, however no study has measured pain beyond 3 days post-surgery.29-32 As such, it is unknown what impact if any acupressure has on the development of chronic pain post-surgery. Also, no study has examined the impact of acupressure on either acute or chronic opioid use. In contrast, the one study that used an acuband (a band worn around the wrist with a nub over the acupressure point to provide stimulation) at the P6 point commonly used to treat nausea and vomiting had no impact on post-surgical pain 24 hours after receiving an appendectomy.
Along with a lack of research on acupressure's impact on chronic pain and opioid use the impact of this intervention on breast cancer patients undergoing surgery (mastectomy, lumpectomy, delayed or immediate reconstruction) is unknown. This study is a pilot randomized clinical trial to explore this intervention in 72 breast cancer patients scheduled for surgery.
- Conditions
- Breast Cancer, Fatigue, Chronic Pain
- Being tested
- Self-administered acupressure
- Medical subject headings
- Breast Neoplasms, Fatigue, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered acupressureOther
Self-administered acupressure learned through app for reduction of need for opioids post-surgery in breast cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Self-administered acupressure | Active comparator | Acupressure administered by participant self-taught from computer application Receives: Other: Self-administered acupressure |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment for self-acupressure: Measure screening to on-study ratio of participants
Measure screening to on-study ratio of participants from Screening to Baseline
Measured: 14 days
Feasibility of training, as measured by number of participants who complete the daily self-reported logbook
Measure the compliance of self-acupressure participants who are using the training application via daily self-reported logbook
Measured: 28 days
Feasibility of training for self-acupressure: Measure the fidelity (accuracy) of participants using training application via instrument administered by study team
Measure the fidelity (accuracy) of participants using training application via instrument administered by study team
Measured: 1 day
Secondary outcomes (2)
Pain mitigation in acute postoperative period measured using the Brief Pain Inventory
Pain will be measured using the Brief Pain Inventory (0 being no pain and 10 being bad as can imagine)
Measured: 2 weeks
Opioid use mitigation in acute postoperative period
Opioid use will be measured across both arms using oral morphine equivalents (OME)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start17 Sep 2018
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Why it stopped: Difficulty recruiting and retaining participants
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 MichiganThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized two arm (intervention and usual care) clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), Michigan Opioid Prescribing Engagement Network (Michigan-OPEN)
- Responsible party
- Principal investigator, Suzanna Zick, University of Michigan
- Investigators
- Suzanna M Zick, ND, MPH, Principal investigator, University of MichiganRichard E Harris, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655600
- Sponsor's protocol ID
- HUM00140468
- Acronym
- AcuPOP
- Status last verified
- Oct 2019
- First submitted
- 6 Aug 2018
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure for Preventing Post-Operative Pain and Opioid Use Among Breast Cancer Patients Receiving Surgery
- ClinicalTrials.gov ID
- NCT03655600
- Acronym / sponsor ID
- AcuPOP / HUM00140468
- Conditions
- Breast Cancer, Fatigue, Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting and retaining participants
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), Michigan Opioid Prescribing Engagement Network (Michigan-OPEN)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 31 Aug 2018 (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.
This study seeks to determine the feasibility of recruiting and training participants in self-acupressure, for women undergoing primary breast cancer surgery or delayed reconstruction surgery. The study seeks to determine also if self-acupressure is effective in reducing the need for opioids post-surgery and the effects on other life factors.
Detailed description
Chronic pain following breast cancer surgery is a significant problem for women. There are over 3 million women in the United States living as breast cancer survivors. Sustained post-surgical pain is one of the most troubling side-effects for these women and continues to affect around 25-60% of breast cancer survivors, with approximately half classifying pain as being moderate to severe. Chronic cancer-related pain is associated with increased fatigue, depression, anxiety, sleep disruption, and decreased quality of life and function.
Acute pre- and post-operative pain are significant predictors of sustained pain following breast cancer surgery, but are insufficiently managed. The etiology of persistent breast cancer related pain following surgery is multifactorial and may be the direct effect of cancer or cancer treatment (e.g. surgery). Known risk factors for this chronic pain include younger age, higher body mass index, type of surgery (axillary lymph node dissection), and presence of a mood disturbance. Cancer patients may develop pain from neurotoxicity from adjuvant chemotherapy, and radiation may also play a role, and causes persistent pain in 13 - 26% of patients.
Two of the most significant factors that determine persistent pain following breast cancer surgery are the degree of pre-surgical pain and acute post-surgical pain. Recent reports have suggested that treatments aimed at reducing these factors may be effective at preventing the development of chronic pain following breast cancer surgery. Existing pre-emptive treatments to reduce this acute surgical pain include the use of nerve blocks and/or pharmacologic agents such as opioids, NSAIDs, ketamine, and gabapentin. While some pharmacologic approaches yield clinically meaningful reductions in post-operative pain in the research setting, there remains controversy in the field. For example in breast surgery specifically, a recent meta-analysis showed that thoracic paravertebral blocks have a statistically significant effect on reducing chronic pain, but the effect was not clinically meaningful and was associated with procedural risks such as vascular puncture.
In addition to the risk of developing pain following breast cancer surgery, women also report increased acute and chronic surgical pain following breast reconstruction surgery. In one of the first studies to examine pain post-reconstruction surgery, Wallace et al. found that the incidence of pain one year following breast cancer mastectomy plus reconstruction was 49% as compared to 31% for mastectomy alone. This increase was both statistically and clinically significant, and remains a current undertreated problem. Overall many women develop persistent pain after breast cancer surgery following either tumor removal or breast reconstruction. We know that this is influenced by acute pre- and post-surgical pain, but unfortunately the existing measures available for clinicians to prevent persistent post-surgical pain are not adequate.
Opioids are commonly used analgesics in the perioperative surgical setting; however, they are accompanied by significant limitations. Opioids are the most common pharmacologic intervention used for acute perioperative surgical pain. They are known to decrease pain via activation of specific receptors (mu, delta, and kappa), which inhibit neuronal firing resulting in reduced nociceptive activity. Although widely prescribed there are significant limitations for opioid use including tolerance, addiction, diversion, and even mortality. There were over 33,000 opioid deaths in the US in 2016 alone and the majority of these have been from opioid prescriptions. The US is currently experiencing an opioid epidemic wherein Americans constitute only 5% of the global population yet we consume over 80% of the world's opioid supply. Unfortunately, while opioids are needed in the surgical setting, the problem of increased opioid use is itself compounded by surgery. Patients receiving even low-risk surgeries are 44% more likely to become de novo long-term opioid consumers. With respect to breast cancer surgery, the odds of developing chronic opioid consumption following mastectomy increases by approximately 300%. Although the reason(s) for developing chronic opioid consumption are largely unknown, patients that receive a new opioid prescription within 7 days post-surgery, as compared to those who do not, are more likely to still be receiving opioids one year out. Thus acute pre-surgical and post-surgical pain, in addition to being risk factors for persistent chronic pain, may also increase the probability of becoming a chronic opioid consumer. There is an unmet need for analgesic interventions that are opioid sparing in the breast cancer surgical setting. This study proposes that acupressure may be one such option.
Acupressure Self-administered acupressure is one possible safe, self-management technique which may be effective for improving post-operative pain and opioid consumption. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease. Prior research has demonstrated that acupressure, self-administered by women with breast cancer, significantly reduced clinically significant pain by approximately one-third and was superior to standard therapies. Moreover, these self-rated improvements were maintained up to one month after treatment was discontinued.
Acupressure has been found to be effective for acute post-surgical pain, but no studies have examined the impact on the development of chronic pain or acute and chronic opioid use in any patient population. Four previous studies in diverse patient populations (appendectomy, cesarean section, gastric cancer, and knee arthroscopy) have found that acupressure delivered by an acupressure practitioner was able to significantly decrease post-surgical pain compared to either usual care or sham acupressure from as early as 60 minutes after surgery to as long as 3 days post-surgery, however no study has measured pain beyond 3 days post-surgery.29-32 As such, it is unknown what impact if any acupressure has on the development of chronic pain post-surgery. Also, no study has examined the impact of acupressure on either acute or chronic opioid use. In contrast, the one study that used an acuband (a band worn around the wrist with a nub over the acupressure point to provide stimulation) at the P6 point commonly used to treat nausea and vomiting had no impact on post-surgical pain 24 hours after receiving an appendectomy.
Along with a lack of research on acupressure's impact on chronic pain and opioid use the impact of this intervention on breast cancer patients undergoing surgery (mastectomy, lumpectomy, delayed or immediate reconstruction) is unknown. This study is a pilot randomized clinical trial to explore this intervention in 72 breast cancer patients scheduled for surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized two arm (intervention and usual care) clinical trial
| Arm | Type | Receives |
|---|---|---|
| Self-administered acupressure | Active comparator | Other: Self-administered acupressureAcupressure administered by participant self-taught from computer application |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of breast cancer stage 0 to III;
- Planned unilateral or bilateral mastectomy or planned delayed breast reconstruction surgery within 24 months following unilateral or bilateral mastectomy;
- For delayed breast reconstruction patients only: apparently cancer free at time of delayed reconstruction;
- No planned new interventions for pain the two weeks prior to surgery;
- Able to self-administer treatment at the specified points.
Key exclusion criteria (8 listed)
- Medically unstable (e.g. uncontrolled diabetes, high blood pressure, etc.);
- For delayed breast reconstruction only: taking aromatase inhibitors which could confound surgical and chronic pain measurements;
- Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder;
- Unwilling to maintain stable does of allowed chronic pain medications (e.g. NSAIDS, benzodiazepines, SSRIs and SNRIs);
- Pregnant, those planning a pregnancy, or lactating mothers;
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 |
|---|---|---|
| Self-administered acupressureSelf-administered acupressure learned through app for reduction of need for opioids post-surgery in breast cancer patients | Other | Self-administered acupressure |
Primary outcome
Feasibility of recruitment for self-acupressure: Measure screening to on-study ratio of participants
Time frame: 14 days
Measure screening to on-study ratio of participants from Screening to Baseline
Feasibility of training, as measured by number of participants who complete the daily self-reported logbook
Time frame: 28 days
Measure the compliance of self-acupressure participants who are using the training application via daily self-reported logbook
Feasibility of training for self-acupressure: Measure the fidelity (accuracy) of participants using training application via instrument administered by study team
Time frame: 1 day
Measure the fidelity (accuracy) of participants using training application via instrument administered by study team
2 secondary outcomes
Pain mitigation in acute postoperative period measured using the Brief Pain Inventory
Time frame: 2 weeks
Opioid use mitigation in acute postoperative period
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Difficulty recruiting and retaining participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- 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.
Suzanna M Zick, ND, MPH principal investigator
University of Michigan
Richard E Harris, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered acupressure in people with Breast Cancer and Fatigue, run by University of Michigan at 1 site 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Oct 2019. 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 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?
The study was stopped early (reason given: Difficulty recruiting and retaining participants). Results are not available in the source record.
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?
Feasibility of recruitment for self-acupressure: Measure screening to on-study ratio of participants (time frame: 14 days). The study lists 3 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 25 Oct 2019.