Acupuncture for Pain Management in Lymphoma

Not currently recruiting at 2 trial locations

Overseen By Sergio Giralt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Low ANC, Low platelets, High INR, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 90

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can reduce the need for opioid medications to manage chemotherapy-related pain in people with lymphoma. Participants will either receive usual pain management, including opioids, or try acupuncture in addition to usual care. The goal is to determine if acupuncture can lessen pain and improve quality of life. The trial seeks individuals diagnosed with certain types of lymphoma who are about to undergo high-dose chemotherapy and have not used opioids regularly in the past week. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in pain management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are not taking opioids regularly in the week before joining. If you have taken opioids for a one-time procedure, that's okay.

Is there any evidence suggesting that acupuncture is likely to be safe for humans?

Research has shown that acupuncture is generally safe when performed by trained professionals. Studies have found that acupuncture can help reduce cancer pain and may lower the need for pain medications like opioids. For instance, one study found that acupuncture was linked to less cancer pain and a reduced need for pain medication.

Another review confirms that acupuncture is safe for cancer patients when performed by trained acupuncturists. Common side effects are usually mild, such as slight bruising or soreness at the needle insertion sites.

Overall, acupuncture is well-tolerated and could be a useful addition to pain management for people with lymphoma undergoing chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard approach for managing pain in lymphoma, which often relies heavily on opioids, acupuncture offers a unique, non-drug alternative for pain relief. Researchers are excited about acupuncture because it targets pain through the body's natural energy pathways, potentially reducing the need for opioid medication and its associated side effects. Additionally, acupuncture might provide relief more quickly and with fewer long-term risks, making it an appealing option for enhancing quality of life during treatment.

What evidence suggests that acupuncture is effective for pain management in lymphoma?

Research has shown that acupuncture can help reduce pain in cancer patients. Studies have found that it manages pain, lowers the need for painkillers, and improves quality of life. A review of several studies linked acupuncture to less cancer pain and a reduced need for pain medication. Additionally, acupuncture has helped with other symptoms like nausea and tiredness in cancer patients. In this trial, one group of participants will receive usual care plus acupuncture, while another group will receive only the usual pain management approach, which includes opioid medication when needed. These findings suggest that acupuncture could be a promising option to manage pain and reduce the need for opioids in lymphoma patients undergoing chemotherapy. ^{1 5 6 7 8}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for high-dose chemotherapy and stem cell transplant within a month, diagnosed with Multiple Myeloma (MM), Hodgkin's Lymphoma (HD), or Non-Hodgkin's Lymphoma (NHL). They shouldn't be regular opioid users or have had acupuncture recently. People with very low white blood cells, platelets, or certain clotting issues can't join.

Inclusion Criteria

I haven't taken opioids regularly in the last week.

I am scheduled for a stem cell transplant within the next month.

I have been diagnosed with multiple myeloma, Hodgkin's disease, or non-Hodgkin's lymphoma.

Exclusion Criteria

Your blood tests show very low levels of infection-fighting white blood cells or blood-clotting platelets, or your blood takes longer than normal to clot.

I have not had acupuncture in the last two weeks.

I am unable to understand and agree to the study's details on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care or usual care plus acupuncture from Day 0 to Day 15

2 weeks

Daily visits for acupuncture if in the experimental group

Follow-up

Participants are monitored for symptom burden and opioid use

12 weeks

Regular follow-up visits until Day 90

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture
• Opioid

Trial Overview The study tests if acupuncture can reduce the need for opioids in managing chemotherapy-induced pain in myeloma and lymphoma patients. It compares usual pain management plus acupuncture to usual care alone, also looking at other symptoms and quality of life impacts.

How Is the Trial Designed?

Group I: Usual Care plus Acupuncture Experimental Treatment 3 Interventions

Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief.

Group II: Usual Care Active Control 2 Interventions

Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11773549/

Efficacy and Safety of Different Acupuncture Treatments for ... This study aims to compare the efficacy and safety of different acupuncture modalities in the treatment of cancer pain through a network meta-analysis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11617358/

The effectiveness of acupuncture in cancer pain treatment - PMC Numerous studies have demonstrated its ability to reduce pain, better control pain, decrease analgesic intake, and significantly improve patients' quality of ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2757396

Clinical Evidence for Association of Acupuncture and ... This systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2022/01280/effectiveness_of_different_acupuncture_therapies.2.aspx

Effectiveness of different acupuncture therapies for chronic ... This study will quantify the effectiveness of each acupuncture intervention for chronic cancer pain with pain scores and the use of analgesics.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268960X22000595

Review Acupuncture in hematologic malignancies and ... Clinical studies show that acupuncture can reduce some of the common symptoms experienced by cancer patients such as nausea and vomiting, pain, fatigue, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532287/

Acupuncture - StatPearls - NCBI Bookshelf - NIH Acupuncture is a system of medical treatment and ideology that is based on the principle of applying small needles or pressure to specific points in the body.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213422019300885

Evidence, safety and recommendations for when to use ... Acupuncture is a safe therapy in cancer care if administered by trained acupuncturists. Acupuncture is targeted to improve symptoms associated with the cancer ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02098928

Comparison Between Hand-acupuncture and Electro ... Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture ...