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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electroacupuncture (EA), a form of acupuncture using a small electric current, can help manage symptoms such as pain, nausea, diarrhea, and insomnia after cancer surgery. The goal is to determine if EA is safe, accepted by patients, and effective in reducing these symptoms. Researchers aim to understand how EA affects certain proteins in the blood linked to these symptoms. Individuals who have undergone a specific type of cancer surgery and chemotherapy and are experiencing these symptoms might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to pioneering research that could enhance symptom management after cancer surgery.

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 prior data suggests that electroacupuncture is safe for symptom management after cancer surgery?

Research has shown that electroacupuncture (EA) is generally safe for managing symptoms in cancer patients. In one small study with 20 cancer patients experiencing pain, EA proved safe, with 85% of patients using it without major issues. This suggests that EA is well-tolerated and might help reduce symptoms such as pain, nausea, and trouble sleeping after cancer surgeries. Although researchers continue to study EA, these findings offer reassurance about its safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for managing symptoms after cancer surgery, which often involve medication or physical therapy, electroacupuncture offers a unique approach by stimulating specific acu-points with electrical currents. Researchers are excited about this technique because it targets the body's natural pain relief and healing mechanisms, potentially reducing reliance on pharmaceuticals and their associated side effects. This non-invasive treatment could provide a safer, more holistic option for patients looking for relief from postoperative symptoms.

What evidence suggests that electroacupuncture is effective for managing symptoms after cancer surgery?

Research has shown that electroacupuncture (EA), which participants in this trial will receive, could help alleviate symptoms after abdominal surgeries. A study that combined results from multiple research papers found that EA is safe and effective for treating postoperative ileus (POI), a condition where the intestines don't function properly after surgery, often occurring with abdominal surgeries. This suggests that EA might also help with similar symptoms, such as pain and nausea, after cancer surgeries. Additionally, EA has significantly reduced pain from various surgeries, including those related to cancer. These findings suggest that EA could effectively lessen pain and other uncomfortable symptoms after cancer surgery. ^{5 6 7 8 9}

Who Is on the Research Team?

Oliver Eng, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6669272/

Transcutaneous electric nerve stimulation (TENS) for cancer ... Transcutaneous Electric Nerve Stimulation (TENS) may have a role in pain management but the effectiveness of TENS is currently unknown.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919119302262

Electroacupuncture or transcutaneous ... This meta-analysis suggests that EA/TEA is a safe, effective treatment for POI after abdominal surgeries including laparoscopic surgery.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11729116/

The healing power of transcutaneous electrical nerve stimulation Transcutaneous electrical stimulation has significantly alleviated pain associated with breast cancer surgery.

4. mdpi.com mdpi.com/1648-9144/58/2/284

Effects of Transcutaneous Electrical Nerve Stimulation on ... TENS is a safe procedure that may be self-administered by the patients with malignancy in an attempt to relieve different types of pain.

5. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/41/1/article-p97.xml

Transcutaneous electrical nerve stimulation for the treatment ... This review concludes that TENS is effective at reducing postoperative pain in spine surgery. Further investigation is needed regarding the optimal settings ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05283577

Study Details | NCT05283577 | Electroacupuncture for the ... To assess the safety and feasibility of administering EA to manage symptom clusters in cancer patients and survivors. As the UCI MINDS C2C registry (UCI IRB ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8876365/

Effects of Transcutaneous Electrical Nerve Stimulation on Pain ... TENS is a safe procedure that may be self-administered by the patients with malignancy in an attempt to relieve different types of pain.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0885392408004351

Transcutaneous Electrical Nerve Stimulation (TENS) for ... We present a case study of successful TENS therapy in a patient with cancer bone pain and discuss the rationale for using TENS in this setting.

9. withpower.com withpower.com/trial/phase-hyperthermia-4-2024-ff78a

Electroacupuncture for Symptom Management After ... 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 ...