Electroacupuncture for Cancer-related Symptoms

(EAST Trial)

Recruiting at 1 trial location

Overseen By Alexandre Chan, PharmD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Metastasis, Severe psychiatric disorders, 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: 10 weeks

88 Participants Needed

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Electroacupuncture for cancer-related symptoms?

Research suggests that Transcutaneous Electrical Nerve Stimulation (TENS), a component of Electroacupuncture, may help manage cancer-related pain, as it is inexpensive and has few side effects. However, the overall effectiveness of TENS for cancer pain is still uncertain, and more studies are needed to confirm its benefits. ^{1 2 3 4 5}

Is electroacupuncture safe for humans?

Research on treatments like electroacupuncture and transcutaneous electrical nerve stimulation (TENS) for cancer-related pain suggests they are generally safe for humans, though their effectiveness can vary. ^{1 2 5 6 7}

How does electroacupuncture differ from other treatments for cancer-related symptoms?

Electroacupuncture (EA) is unique because it combines traditional acupuncture with electrical stimulation, which may help reduce cancer-related pain by affecting pain pathways differently than standard pain medications. Unlike opioids, EA does not cause immunosuppression, making it a potentially safer option for managing pain without the side effects associated with opioid use. ^{2 5 8 9 10}

What is the purpose of this trial?

This is a sham-controlled, patient and assessor-blinded pilot trial to evaluate the feasibility of administering EA as an intervention for symptom clusters in cancer patients and survivors, and to evaluate the degree that EA could reduce symptom clusters and the possible underlying mechanisms through examining its influence on biomarkers that are linked with the symptoms. Participants will be randomized to either the treatment arm (those who will receive EA) or the control arm (those who will receive sham-EA). The treatment period for both groups will be 10 weeks. There will be one study visit a week over the course of the 10-week treatment period, for a total of 10 study treatment visits. Participants in the treatment arm will receive EA at 13 standardized acu-points that have been chosen for their therapeutic effects. Participants in the control arm will receive electrical stimulation at non-disease acu-points. There will be four data collection time points for each participant: (1) baseline, (2) mid-treatment (5 weeks from baseline), (3) end of treatment (10 weeks from baseline), and (4) 4 weeks after end of treatment (14 weeks from baseline). At each of these timepoints, 10mL of peripheral blood will be collected for a biomarker analysis and participants will be asked to complete 4 questionnaires and a computerized cognitive test to evaluate their cognitive function, fatigue level, insomnia, psychological distress, and quality of life. An optional neuroimaging procedure will be available to all eligible participants. In total, study participation will last for 14 weeks.

Research Team

Alexandre Chan, PharmD

Principal Investigator

UCI

Eligibility Criteria

This trial is for cancer patients and survivors, aged 16 or older, who have a life expectancy of at least 6 months and are experiencing symptoms like memory issues, fatigue, insomnia, depression or anxiety. They must not be pregnant, breastfeeding or planning to become pregnant during the study. People with metastasis, severe needle phobia, major psychiatric conditions affecting cognition, bleeding disorders or epilepsy cannot join.

Inclusion Criteria

Life expectancy ≥ 6 months

I have experienced symptoms like memory issues, fatigue, insomnia, depression, or anxiety in the last week.

I have cancer and have received treatment for it.

Exclusion Criteria

I am currently receiving or have received acupuncture in the last 3 months.

Severe needle phobia

I have a known bleeding disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either electroacupuncture (EA) or sham-EA for symptom management over a 10-week period

10 weeks

10 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomarker analysis and cognitive assessments

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Electroacupuncture
• Sham-Electroacupuncture

Trial Overview The trial tests Electroacupuncture (EA) against Sham-Electroacupuncture to manage symptom clusters in cancer patients/survivors over a 10-week period with weekly sessions. It also examines EA's effects on biomarkers related to these symptoms through blood tests and questionnaires assessing cognitive function and quality of life.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Each participant will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Each EA session will be approximately 1 hour. Participants in the treatment arm will receive EA at 13 standardized acu-points that were chosen for their therapeutic effects.

Group II: Control Arm Placebo Group 1 Intervention

Each participant in the control arm will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Participants in the control arm will receive electrical stimulation at non-disease related acu-points for approximately 1 hour per session.

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]

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 systematic review included three randomized controlled trials (RCTs) with a total of 88 participants, but the results remain inconclusive regarding the effectiveness of Transcutaneous Electric Nerve Stimulation (TENS) for managing cancer-related pain.

One study suggested that TENS might improve bone pain during movement in cancer patients, but overall, there were no significant differences between TENS and placebo treatments, indicating a need for larger, more robust studies to determine its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Hurlow, A., Bennett, MI., Robb, KA., 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]

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]

Electroacupuncture (EA) at the Neimadian-point significantly reduced cancer pain in patients compared to a control group receiving sham EA and Sufentanil, with better pain relief observed at multiple time points after treatment.

EA not only decreased pain levels but also positively influenced plasma levels of pain-related substances, showing a greater ability to modulate norepinephrine and serotonin compared to traditional analgesics, indicating its potential as an effective pain management strategy for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical trial of electroacupuncture at Neimadian-point for cancer pain]. Han, XC., Xing, QZ., Li, Y., et al.[2021]

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]

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]

Acupuncture has been shown to be a safe and effective treatment for various symptoms associated with cancer, including nausea, pain, fatigue, and insomnia, based on a systematic review of 23 clinical trials.

The evidence suggests that acupuncture can help minimize side effects from conventional cancer treatments, improving patients' overall quality of life during their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture techniques and acupoints used in individuals under chemotherapy or radiotherapy treatment of cancer: A systematic review. de Sousa, TR., Mattos, S., Marcon, G., et al.[2023]

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. 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. 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]

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

Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. [2022]

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

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

5. 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]

6. China pubmed.ncbi.nlm.nih.gov

[Clinical trial of electroacupuncture at Neimadian-point for cancer pain]. [2021]

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

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]

9. England pubmed.ncbi.nlm.nih.gov

Acupuncture techniques and acupoints used in individuals under chemotherapy or radiotherapy treatment of cancer: A systematic review. [2023]

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

Acupuncture for cancer pain and related symptoms. [2022]