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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

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 groups in NCT03655600
Study groupRoleWhat they receive
Self-administered acupressureActive comparatorAcupressure administered by participant self-taught from computer application
Receives: Other: Self-administered acupressure
Usual careNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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.

  1. First posted31 Aug 2018
  2. Study start17 Sep 2018
  3. Primary completion17 Oct 2019
  4. Study completion17 Oct 2019

Why it stopped: Difficulty recruiting and retaining participants

Resources

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)
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

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.

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