Electroacupuncture for Cancer-related Symptoms

(EAST Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electroacupuncture, which uses tiny electrical currents through acupuncture needles, can ease common symptoms faced by cancer patients and survivors, such as memory issues, fatigue, insomnia, depression, or anxiety. Participants will receive either the actual treatment or a placebo version for 10 weeks to compare effects. The goal is to determine if this treatment can improve quality of life by reducing these symptoms and to study possible changes in blood markers related to them. Patients who have undergone cancer treatment and experience one or more of these symptoms might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore a novel approach to symptom relief and improve quality of life.

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 prior data suggests that electroacupuncture is safe for cancer-related symptoms?

Research has shown that electroacupuncture is generally safe. Similar treatments, such as Transcutaneous Electrical Nerve Stimulation (TENS), have been used without major safety issues. Patients with cancer-related pain often use TENS, indicating it is well-tolerated.

Although TENS may vary in effectiveness for pain relief among individuals, its safety record is reassuring. Most patients experience few, if any, side effects with these electrical stimulation methods. The aim is to relieve symptoms without causing harm, and current data supports the safety of this treatment for cancer-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electroacupuncture for managing cancer-related symptoms because it offers a non-drug approach that could minimize side effects associated with conventional treatments like opioids or anti-nausea medications. Unlike standard cancer symptom treatments that often work by altering chemical pathways in the brain and body, electroacupuncture uses electrical stimulation at specific acu-points to potentially ease symptoms like pain and fatigue. This method leverages the body's natural healing processes, which might provide relief without the common side effects of medications, leading to a better quality of life for patients.

What evidence suggests that electroacupuncture might be an effective treatment for cancer-related symptoms?

Research has shown that electroacupuncture, which participants in this trial may receive, might help manage certain symptoms. One study found it more effective than TENS (a type of electrical therapy) for treating functional constipation, suggesting it could provide symptom relief. Although specific evidence for cancer-related symptoms remains limited, electroacupuncture targets certain points that may reduce discomfort and improve quality of life. These benefits likely stem from its effect on the body's natural pain and stress relief systems. While more research is needed, early findings suggest electroacupuncture could help manage symptoms in cancer patients. Participants in the control arm of this trial will receive Sham-Electroacupuncture, which involves electrical stimulation at non-disease-related acu-points. ^{2 6 7 8 9}

Who Is on the Research Team?

Alexandre Chan, PharmD

Principal Investigator

UCI

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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 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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07051265

Effect of Transcutaneous Electrical Nerve Stimulation or ... This clinical trial aims to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS), acupressure intervention, or standard care ...

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

Effects of Transcutaneous Electrical Nerve Stimulation on ... Based on the results, no strict recommendations concerning TENS usage in the cancer patient population could be issued. However, the existing evidence allows us ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0885392408004569

A Cochrane Systematic Review of Transcutaneous ... The aim of this systematic review was to evaluate the literature describing the effectiveness of TENS in the management of cancer-related pain in adults.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2018/05110/efficacy_of_electroacupuncture_compared_with.37.aspx

Efficacy of electroacupuncture compared with ... This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation.

6. 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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05283577

Study Details | NCT05283577 | Electroacupuncture for the ... The purpose of this study is to investigate the efficacy, safety, and feasibility of offering electroacupuncture as an intervention to improve cancer-related ...

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. physio-pedia.com physio-pedia.com/Transcutaneous_Electrical_Nerve_Stimulation_(TENS)

Transcutaneous Electrical Nerve Stimulation (TENS) TENS is a form of electrical stimulation which mainly aims at symptomatic pain relief by exciting sensory nerves and thereby stimulating either the pain ...