Acupuncture vs Massage for Cancer Pain

Not currently recruiting at 7 trial locations

Overseen By Gary Deng, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Low platelets, Cognitive impairment, others

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

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

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares acupuncture and massage to determine which better alleviates pain and improves quality of life for people with advanced cancer. Participants will receive either acupuncture or massage treatments over several months. It suits those with advanced cancer who frequently experience musculoskeletal pain (pain in muscles, bones, or joints) and can move independently. The goal is to identify which treatment more effectively manages cancer-related pain. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that acupuncture is generally safe for people with cancer. A review found it to be a safe treatment in cancer care, with minimal risks. People with cancer typically tolerate it well, and it rarely causes side effects.

Studies have also shown that massage therapy is safe for cancer patients. Although deep tissue massage is not recommended, regular massage by a trained therapist rarely causes problems. Some individuals might experience mild bruising, but serious issues are uncommon.

Both acupuncture and massage can help reduce cancer pain. They are safe options for those seeking to manage pain and improve quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about acupuncture and massage for managing cancer pain because they offer non-drug alternatives that focus on holistic pain relief. Unlike traditional pain management options like opioids and NSAIDs, acupuncture stimulates specific points on the body to potentially relieve pain by releasing endorphins and improving blood flow. Massage therapy, on the other hand, may alleviate pain by reducing muscle tension and promoting relaxation. These treatments provide a complementary approach that could reduce reliance on medications, thereby minimizing side effects and improving the overall quality of life for cancer patients.

What evidence suggests that acupuncture and massage could be effective for cancer pain?

This trial will compare the effectiveness of acupuncture and massage for cancer pain. Studies have shown that acupuncture effectively reduces cancer pain, lowering pain levels and improving patients' overall quality of life. Some patients even prefer it over medication for pain management. Meanwhile, massage therapy also has strong evidence supporting its ability to reduce cancer pain. Research shows that massage can significantly decrease pain and other symptoms like stress and anxiety. Both treatments, tested in separate arms of this trial, have been linked to long-term pain relief in cancer patients. ^{1 6 7 8 9}

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?

The IMPACT trial is for adults over 18 with advanced cancer and a life expectancy of more than six months. Participants must be able to move around, have had musculoskeletal pain rated at least 4 out of 10 for the past month, and not just have non-musculoskeletal pain. They should also agree to random treatment assignment and commit to a 26-week study period.

Inclusion Criteria

I can care for myself but may need occasional help.

I have had muscle or joint pain, with or without nerve pain, for at least a month, rating 4 or more in severity.

Your doctor thinks you will live for at least six more months.

Exclusion Criteria

I am not willing to commit to a 26-week study.

My only pain comes from non-muscle/bone conditions.

You have trouble thinking and remembering things, which would make it hard for you to do the tests in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 10 acupuncture or massage treatments in the first 10 weeks

10 weeks

Up to 10 visits (in-person)

Booster Treatment

Participants receive monthly booster treatments for up to 26 weeks

16 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture
• Massage

Trial Overview This study compares acupuncture with massage in managing pain for people with advanced cancer. It aims to see which method better helps reduce pain, improves related symptoms, and enhances quality of life over the long term.

How Is the Trial Designed?

Group I: Acupuncture Experimental Treatment 1 Intervention

Participants will receive up to 10 treatments in the first 10 weeks (+/- 4 days) and then receive monthly booster treatments (+/- 7 days) for up to 26 weeks.

Group II: Massage Active Control 1 Intervention

Participants will receive up to 10 treatments in the first 10 weeks (+/- 4 days) and then receive monthly booster treatments (+/- 7 days) for up to 26 weeks.

Acupuncture is already approved in United States, European Union, China for the following indications:

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

Acupuncture is recommended by the American Cancer Society for managing cancer-related symptoms like pain and nausea, and it has been shown to be effective in alleviating these symptoms in cancer patients.

Despite concerns from some practitioners about the potential risks of 'dispersing' tumors, acupuncture can be safely administered using distant points, and it may even have immunomodulatory effects that could be beneficial for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acupuncture for cancer patients: why not?]. Samuels, N.[2006]

Acupuncture has a relatively low risk of adverse events (AEs), with at least one AE occurring in about 9.31% of patients undergoing treatment, and serious adverse events (SAEs) being very rare at approximately 1.01 per 10,000 patients.

The most common minor AEs are mild reactions such as bleeding or pain at the needle site, which are often considered intended effects of acupuncture, highlighting the need for standardized assessment tools to differentiate between adverse reactions and therapeutic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. Bäumler, P., Zhang, W., Stübinger, T., et al.[2021]

Acupuncture is recognized as a safe and effective treatment for managing acute chemotherapy-induced nausea and vomiting in cancer patients, supported by recent clinical trials and research on its physiological mechanisms.

The growing acceptance of acupuncture in oncology settings highlights its role in supportive care, with many cancer clinics now recommending and administering this treatment to alleviate side effects from conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in the oncology setting: clinical trial update. Capodice, JL.[2021]

Citations

1. 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2095496424000268

Systematic Review Efficacy of acupuncture on cancer pain Acupuncture was more effective in reducing pain than no treatment (SMD = –0.90, 95 % CI [–1.68, –0.12]), sham acupuncture (SMD = –1.10, 95 % CI [–1.59, –0.61]) ...

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

Efficacy and Safety of Different Acupuncture Treatments for ... A randomized clinical trial showed that acupuncture was not only effective in reducing pain scores and relieving pain, but also improved fatigue ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811822

Acupuncture vs Massage for Pain in Patients Living With ... In this randomized clinical trial that included 298 patients with advanced cancer, both acupuncture and massage were associated with long-term pain reduction.

5. cmjournal.biomedcentral.com cmjournal.biomedcentral.com/articles/10.1186/s13020-021-00558-4

Acupuncture for cancer pain: an evidence-based clinical ... Around one third of cancer pain patients (ranged 27% to 42%) preferred acupuncture over medication for pain management.

6. nccih.nih.gov nccih.nih.gov/health/acupuncture-effectiveness-and-safety

Acupuncture: Effectiveness and Safety - nccIH.nih.gov In a 2018 review, data from 10 studies (2,413 participants) showed acupuncture was more effective than no treatment for osteoarthritis pain, and data from 9 ...

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

Evidence, safety and recommendations for when to use ... Acupuncture is moderately or weakly effective for 19 symptoms in patients with cancer and cancer survivors. Acupuncture is a safe therapy in cancer care if ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34165

Safety of acupuncture in oncology: A systematic review and ... According to this analysis, acupuncture is a safe therapy for the treatment of patients with cancer. Acupuncture seems to be safe compared with ...

9. 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 ...