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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.

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 data supports the effectiveness of the treatment Acupuncture Therapy for postoperative pain in cancer surgery?

Research shows that acupuncture, when combined with usual care, can reduce pain and improve mood in postoperative cancer patients compared to usual care alone. In a study, patients receiving acupuncture experienced a greater reduction in pain and depressive mood than those who did not receive the treatment. ^{1 2 3 4 5}

Is acupuncture safe for treating postoperative pain in cancer surgery?

Research on acupuncture for postoperative pain, including in cancer surgery, generally suggests it is safe for humans. Studies have evaluated its safety and effectiveness, indicating it can be part of a multimodal approach to pain management without significant safety concerns. ^{2 3 4 5 6}

How does acupuncture differ from other treatments for postoperative pain in cancer surgery?

Acupuncture is unique because it is a non-drug treatment that involves inserting thin needles into specific points on the body to manage pain. Unlike traditional pain medications, acupuncture can reduce the need for analgesics (pain relievers) and is recommended as part of an integrative approach to managing cancer-related pain. ^{2 5 7 8 9}

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Symptom management with massage and acupuncture in postoperative cancer patients: a randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture for the treatment of postoperative pain: A protocol for a systematic review of randomized controlled trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Acupuncture for postoperative pain in laparoscopic surgery: a systematic review protocol. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for postoperative pain after gynecological surgery: a randomized controlled trail. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a special acupuncture technique for pain after thoracotomy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of acupuncture to reduce cancer-related pain. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for cancer pain and related symptoms. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Unilateral Acupuncture Reduces Postoperative Pain Scores in Children Undergoing Adenotonsillectomy: A Randomized Controlled Trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Acupuncture as a treatment modality for the management of cancer pain: the state of the science. [2012]