Electroacupuncture for Symptom Management After Cancer Surgery

Recruiting at 1 trial location

Overseen By Alexandre Chan, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Untreated neoplasm, Metastases, Illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators are conducting this research study is to evaluate the feasibility (recruitment, compliance, safety, and acceptance) of using electroacupuncture (EA) to manage complex symptoms such as pain, nausea/vomiting, diarrhea, and insomnia in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. Additionally, the investigators are aiming to determine the effectiveness of EA in reducing these symptoms, and to examine how EA impacts important biomarkers, or proteins in the blood, that can be used as indicators or signs of these symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of Electroacupuncture for symptom management after cancer surgery?

Research shows that treatments similar to Electroacupuncture, like Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS), have been used to manage pain in cancer patients. For instance, PENS has shown a consistent decrease in postoperative pain in gynecologic oncology patients, and TENS has been successfully used for cancer bone pain, suggesting potential benefits for symptom management after cancer surgery. ^{1 2 3 4 5}

Is electroacupuncture safe for humans?

Transcutaneous electrical nerve stimulation (TENS), a similar treatment to electroacupuncture, is generally considered safe and is relatively free from side effects, making it a widely available option for managing pain. ^{1 3 5 6 7}

How does the treatment Electroacupuncture differ from other treatments for symptom management after cancer surgery?

Electroacupuncture (EA) is unique because it combines traditional acupuncture with electrical stimulation, which may enhance its effectiveness in managing pain and other symptoms after cancer surgery. Unlike standard drug treatments, EA targets specific points on the body to potentially reduce pain and improve recovery without the side effects associated with medications. ^{1 6 8 9 10}

Research Team

Oliver Eng, MD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for patients who've had Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy to treat cancer. It's designed to see if electroacupuncture can help manage symptoms like pain, nausea, vomiting, diarrhea, and insomnia post-surgery.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

My organ and bone marrow functions are within normal ranges.

Expected survival greater than 9 months

Exclusion Criteria

I have not had any cancer other than skin cancer in the last 5 years.

Patients with uncontrolled intercurrent illness

Patients with psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Assessment

Baseline assessments including surveys and inflammatory markers obtained at the preoperative visit

1 day

1 visit (in-person)

Treatment

Participants receive electroacupuncture interventions weekly for 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Completion assessment performed at approximately 6 months post-surgery to monitor safety and effectiveness

6 months

1 visit (in-person)

Treatment Details

Interventions

• Electroacupuncture

Trial Overview The study tests the use of electroacupuncture as a treatment for managing symptoms after specific cancer surgeries. The goal is to assess how well it works (effectiveness), how safe it is (safety), and whether patients are willing to stick with it (compliance).

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Each participant will attend a total of 8 treatment visits (one visit per week), over the course of 8 weeks. Each EA session will be approximately 1 hour. Participants in the treatment arm will receive EA at 10 standardized acu-points that were chosen for their therapeutic effects.

Electroacupuncture is already approved in China, United States, European Union for the following indications:

Approved in China as Electroacupuncture for:

• Pain relief
• Chronic pain
• Muscle spasms
• Paralysis
• Neurological diseases

Approved in United States as Electroacupuncture for:

• Pain management
• Chronic pain disorders
• Nausea and vomiting

Approved in European Union as Electroacupuncture for:

• Pain relief
• Chronic pain
• Rheumatoid arthritis

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

In a pilot study involving 20 patients with cancer pain, transcutaneous electrical nerve stimulation (TENS) was found to be safe, with 85% of patients using intensity-modulated TENS (IMT) reporting at least slight pain improvement compared to 50% with placebo TENS (PBT).

However, the overall change in average pain intensity did not significantly differ between IMT and PBT, suggesting that while TENS may be desired by patients, it may not provide greater analgesic effects than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. Siemens, W., Boehlke, C., Bennett, MI., et al.[2021]

In a study involving 20 postoperative gynecologic oncology patients, percutaneous electrical nerve stimulation (PENS) showed a consistent decrease in pain after each treatment compared to traditional acupuncture, indicating its potential for more immediate pain relief.

However, after 48 hours, both PENS and traditional acupuncture provided equivalent levels of pain relief, suggesting that while PENS may offer quicker results, both methods are effective for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain: acupuncture versus percutaneous electrical nerve stimulation. Gavronsky, S., Koeniger-Donohue, R., Steller, J., et al.[2014]

This multicenter trial will evaluate the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with opioid drugs in treating moderate to severe cancer-related pain in 160 patients over a three-week period, aiming to improve pain management and reduce opioid side effects.

The study will assess primary outcomes through changes in pain scores and morphine dosage, while also examining the potential benefits of TEAS on immune function and overall quality of life, addressing a significant gap in current cancer pain management research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial. Liang, Y., Bao, G., Gong, L., et al.[2020]

This clinical trial will evaluate the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) combined with opioids in managing moderate to severe cancer-related pain in 104 patients with hepatocellular carcinoma (HCC).

The study aims to assess pain relief and quality of life improvements using various measures, including the Numerical Rating Scale (NRS) and the Brief Pain Inventory (BPI), over a treatment period of one week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acupoint Stimulation for Moderate to Severe Pain in Hepatocellular Carcinoma: A Protocol for a Randomized Controlled Trial. Wu, P., Zhu, L., Zheng, SY., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) therapy was successfully used to treat a patient with painful bony metastases from cancer, highlighting its potential as an effective pain management option.

TENS is a cost-effective and low-side-effect alternative to traditional treatments like opioids and radiotherapy, which can have significant side effects and variable effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for cancer bone pain. Searle, RD., Bennett, MI., Johnson, MI., et al.[2011]

Electroacupuncture (EA) at the ST36 acupoint significantly reduced cancer-induced pain in rats, as evidenced by improved paw withdrawal thresholds and decreased nocifensive behavior after cancer cell injection.

EA treatment also counteracted the upregulation of TRPV1 expression in the dorsal root ganglions (DRGs), suggesting that its pain-relieving effects may be linked to the suppression of this pain-related receptor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of electroacupuncture at the ST36 (Zusanli) acupoint on cancer pain and transient receptor potential vanilloid subfamily 1 expression in Walker 256 tumor-bearing rats. Zhang, Z., Wang, C., Gu, G., et al.[2022]

Transcutaneous electrical acupoint stimulation (TEAS) effectively alleviates mild to moderate bone metastasis pain in cancer patients, showing similar efficacy to drug treatments, based on a study of 127 patients.

TEAS not only helps reduce anxiety but also improves immune function by preventing the decline of B cells and CD8 T cells, suggesting it may offer additional benefits beyond pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of therapeutic effect of transcutaneous electrical acupoint stimulation on bone metastasis pain and its influence on immune function of patients. Tai, JB., Hong, L., Ma, ME., et al.[2021]

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]

Acupuncture is highlighted as an important integrative therapy for managing chronic pain in cancer survivors, as recommended by the American Society of Clinical Oncology's recent guidelines.

The review focuses on randomized clinical trials showing acupuncture's effectiveness in treating specific pain conditions related to cancer treatment, such as chemotherapy-induced peripheral neuropathy and post-surgical pain, indicating its potential role in improving quality of life for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Acupuncture for Chronic Pain in Cancer Survivors: A Reflection on the American Society of Clinical Oncology Chronic Pain Guideline. Lu, W., Rosenthal, DS.[2022]

In a study involving 183 cancer patients, acupuncture treatment significantly reduced symptom intensity from a mean score of 7.04 to 2.56 on a visual analogue scale, indicating a 63.6% improvement in symptom control.

The positive effects of acupuncture were consistent across various symptoms, including oncological pain, chemotoxicity, and chronic postoperative pain, suggesting its potential as an effective complementary therapy in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of acupuncture for cancer symptoms in a cancer institute in Brazil. D'Alessandro, E., de Brito, C., Cecatto, R., et al.[2013]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. [2021]

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

Postoperative pain: acupuncture versus percutaneous electrical nerve stimulation. [2014]

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

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial. [2020]

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

Transcutaneous Electrical Acupoint Stimulation for Moderate to Severe Pain in Hepatocellular Carcinoma: A Protocol for a Randomized Controlled Trial. [2022]

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

Transcutaneous electrical nerve stimulation (TENS) for cancer bone pain. [2011]

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

The effects of electroacupuncture at the ST36 (Zusanli) acupoint on cancer pain and transient receptor potential vanilloid subfamily 1 expression in Walker 256 tumor-bearing rats. [2022]

7. China pubmed.ncbi.nlm.nih.gov

Evaluation of therapeutic effect of transcutaneous electrical acupoint stimulation on bone metastasis pain and its influence on immune function of patients. [2021]

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

Acupuncture for cancer pain and related symptoms. [2022]

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

Oncology Acupuncture for Chronic Pain in Cancer Survivors: A Reflection on the American Society of Clinical Oncology Chronic Pain Guideline. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of acupuncture for cancer symptoms in a cancer institute in Brazil. [2013]