Acupuncture for Postoperative Pain in Cancer Surgery

Overseen By Wenli Liu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Opioids

Disqualifiers: Seizures, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of acupuncture therapy in managing pain after surgery for colorectal or pancreatic cancer. Researchers aim to determine if acupuncture can reduce pain and other side effects, facilitating a smoother recovery. The trial includes two groups: one receiving acupuncture along with usual care, and the other receiving only usual care. Eligible participants have undergone surgery for colorectal or pancreatic cancer and can read and understand English. As an unphased trial, this study provides a unique opportunity to explore alternative pain management options post-surgery.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using chronic opioids at a high dose, you may not be eligible to participate.

What prior data suggests that acupuncture therapy is safe for managing postoperative pain?

Research has shown that acupuncture is generally safe for managing pain. Studies indicate that it can reduce pain, improve pain control, and decrease the need for pain medication. For instance, acupuncture improved short-term pain relief after surgery, with fewer requests for additional painkillers.

Regarding safety, acupuncture is usually well-tolerated, with few reports of serious side effects. Minor issues, such as slight bleeding or bruising at needle insertion sites, can occur but are rare. Overall, acupuncture is considered a safe option for many people dealing with pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for postoperative pain in cancer surgery rely on medications like opioids and nonsteroidal anti-inflammatory drugs (NSAIDs). However, acupuncture therapy is unique because it offers a non-drug approach to managing pain, potentially reducing the need for these medications and their associated side effects. Researchers are excited about acupuncture because it targets the body's natural pain relief mechanisms, stimulating specific points to release endorphins and promote healing. This approach might not only enhance recovery but also improve overall patient comfort and well-being without the risks of conventional pain medications.

What evidence suggests that acupuncture is effective for managing postoperative pain?

Research has shown that acupuncture can help reduce pain after surgery. Various studies have found that acupuncture eases pain more effectively than no treatment or even sham acupuncture. One study discovered that acupuncture reduced the need for opioids and improved pain relief on the first day after surgery. Another review highlighted that acupuncture can better manage cancer pain, reducing the need for painkillers and improving quality of life. In this trial, one group of participants will receive acupuncture therapy alongside usual care, while another group will receive usual care alone. These findings suggest that acupuncture could be a promising option for managing pain after cancer surgery. ^{1 2 4 5 6}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking patients with pancreatic or colorectal cancer who are undergoing open surgery. They must be able to consent and follow the study's rules. People using high doses of opioids, those with bowel obstruction, recent major surgery, seizures, cognitive issues, or conditions preventing acupuncture can't join.

Inclusion Criteria

I am having surgery for pancreatic or colorectal cancer.

Able to consent to treatment

Sign a written informed consent and willing to follow protocol requirements

Exclusion Criteria

I have a blockage in my intestines.

I have no infections or issues that prevent acupuncture.

I will not be admitted to the ICU immediately after my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo acupuncture sessions over 25 minutes once daily for up to 7 days, along with usual care including preoperative and postoperative evaluations and visits.

7 days

Daily visits for acupuncture

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postoperative length of stay and dietary recovery.

Up to 7 days

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture Therapy

Trial Overview The study is testing if acupuncture can manage pain after pancreatic or colorectal surgery better than usual care practices. Patients will receive acupuncture therapy alongside standard postoperative procedures and their pain levels will be monitored through questionnaires.

How Is the Trial Designed?

Group I: Arm I (acupuncture, usual care) Experimental Treatment 3 Interventions

Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes QD for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.

Group II: Arm II (usual care) Active Control 2 Interventions

Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

This study aims to systematically review the effectiveness and safety of acupuncture for treating postoperative pain (PPP) by analyzing randomized controlled trials from various comprehensive databases.

The primary focus will be on measuring postoperative pain intensity, while secondary outcomes will include analgesic consumption, recovery parameters, vital signs, quality of life, and any treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture for the treatment of postoperative pain: A protocol for a systematic review of randomized controlled trial. Zhang, Q., Yue, JH., Sun, ZR., et al.[2020]

This systematic review aims to evaluate the effectiveness and safety of acupuncture for managing postoperative pain in patients after laparoscopic surgery, analyzing data from various international databases.

The review will include randomized controlled trials and assess the risk of bias, potentially providing valuable insights for clinicians and patients regarding the use of acupuncture in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for postoperative pain in laparoscopic surgery: a systematic review protocol. Lee, S., Park, J., Kim, J., et al.[2019]

Acupuncture is recommended by the National Comprehensive Cancer Network as an effective integrative intervention for managing cancer pain, highlighting its role alongside pharmacological treatments.

The review provides specific acupuncture protocols for various cancer-related pain conditions, such as postoperative pain and chemotherapy-induced neuropathy, offering practical solutions for clinicians and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for cancer pain and related symptoms. Lu, W., Rosenthal, DS.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11617358/

The effectiveness of acupuncture in cancer pain treatment - PMC Numerous studies have demonstrated its ability to reduce pain, better control pain, decrease analgesic intake, and significantly improve patients' quality of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2095496424000268

Systematic Review Efficacy of acupuncture on cancer pain Acupuncture was more effective in reducing pain than no treatment (SMD = –0.90, 95 % CI [–1.68, –0.12]), sham acupuncture (SMD = –1.10, 95 % CI [–1.59, –0.61]) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04560712?cond=pancreatic+cancer&aggFilters=status%3A%2Cphase%3A

Acupuncture for the Management of Postoperative Pain in ... Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0150367

The Efficacy of Acupuncture in Post-Operative Pain ... Our findings indicate that certain modes of acupuncture improved postoperative pain on the first day after surgery and reduced opioid use.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2019/12060/effectiveness_of_acupuncture_for_the_treatment_of.1.aspx

Effectiveness of acupuncture for the treatment of... : Medicine This aim of this study is to assess the effectiveness and safety of acupuncture for the treatment of patients with postoperative pain (PPP).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9859706/

Effect of Acupuncture on Postoperative Pain in Patients after ... Acupuncture can clinically improve the short-term treatment of postoperative pain after LC and reduce the request for extra analgesics.