What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma include chemotherapy, immunotherapy, targeted therapy, and stem cell transplants. These treatments can cause side effects such as fatigue, nausea, vomiting, infections, and neuropathy. Neuromodulation techniques like transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), which are similar to acupuncture in their pain relief mechanisms, have mild side effects. These include sensations like warmth, tingling, and muscle spasms, with no serious adverse events reported. Acupuncture itself is generally safe, with rare side effects such as minor bleeding or bruising at needle sites.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Myeloma include various chemotherapeutic agents and targeted therapies. Notable drugs include bortezomib, lenalidomide, and carfilzomib, which are proteasome inhibitors, and daratumumab, an anti-CD38 monoclonal antibody. These treatments aim to manage the disease and alleviate symptoms, including pain. Acupuncture, while not FDA-approved specifically for Multiple Myeloma, is being studied for its potential to reduce pain and opioid use through neuromodulation and endorphin release.

What other types of research exist?

Promising novel alternatives to acupuncture for pain relief in multiple myeloma patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in neuromodulation and pain relief; 2) Music Therapy, which can modulate pain perception and improve psychological outcomes; 3) Massage Therapy, which has been effective in reducing pain and improving mood; and 4) Guided Imagery and Progressive Muscle Relaxation, which can help manage pain and reduce stress. These therapies offer non-pharmacological pain relief through mechanisms similar to those of acupuncture.

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Acupuncture for Pain Management in Lymphoma

Phase 3

Waitlist Available

Led By Gary Deng, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Pathological diagnosis of MM, HD or NHL

Must not have

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 90

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is investigating whether acupuncture can help reduce the need for opioid painkillers in patients experiencing pain from chemotherapy. Acupuncture involves inserting thin needles into specific points on the body to relieve pain. The study aims to see if this method can lessen pain and improve quality of life for these patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Acupuncture may cause minor side effects like bruising, bleeding at needle sites, dizziness, or fainting. Opioids can lead to addiction risk, constipation, nausea, drowsiness, confusion and respiratory depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Symptom Burden

the Number of Patients Using Opioids at a Given Time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Usual Care plus AcupunctureExperimental Treatment3 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 CareActive Control2 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments often include chemotherapy, immunotherapy, targeted therapy, and stem cell transplants. Chemotherapy works by killing rapidly dividing cancer cells, while immunotherapy boosts the body's immune system to fight cancer. Targeted therapies specifically attack cancer cells with minimal damage to normal cells. Stem cell transplants replace damaged bone marrow with healthy cells. Acupuncture, as studied for pain relief in Multiple Myeloma patients, works through neuromodulation and the release of endorphins, which can help manage pain and improve quality of life. This is particularly important for Multiple Myeloma patients, who often experience significant pain and symptom burden due to their disease and its treatments.

The Assessment and Treatment of Inpatient Cancer-Related Pain with Acupuncture: Development of a Manual.Acupuncture for Opioid Dependence Patients Receiving Methadone Maintenance Treatment: A Network Meta-Analysis.