Acupuncture for Pain Management in Lymphoma

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

299 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of acupuncture as a treatment for pain management in lymphoma?

Research shows that acupuncture can help manage cancer pain and reduce the need for opioid drugs, which are often used for severe pain. It has been effective in reducing pain and symptoms like nausea and drowsiness in cancer patients, suggesting it could be a helpful addition to pain management strategies. ^{1 2 3 4 5}

How does acupuncture differ from other treatments for pain management in lymphoma?

Acupuncture is unique because it is a non-drug therapy that involves inserting thin needles into specific points on the body to manage pain, potentially reducing the need for opioids and addressing the total pain experience in cancer patients. Unlike conventional pain medications, acupuncture offers an integrative approach that can be tailored to individual symptoms and is considered safe for cancer survivors. ^{4 6 7 8 9}

Research Team

Gary Deng, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Acupuncture/Electroacupuncture as an Alternative in Current Opioid Crisis. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Acupuncture combined with opioid drugs on moderate and severe cancer pain: a randomized controlled trial]. [2020]

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

Acupuncture for cancer pain and related symptoms. [2022]

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

Acupuncture As a Potential Opioid-Sparing Pain Management Intervention for Patients Undergoing Cancer Treatment. [2021]

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

Randomized controlled trial of a special acupuncture technique for pain after thoracotomy. [2021]

6. United States 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. [2022]

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

Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial. [2022]

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

Understanding the Benefits of Acupuncture Treatment for Cancer Pain Management. [2022]

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

The Assessment and Treatment of Inpatient Cancer-Related Pain with Acupuncture: Development of a Manual. [2023]