Acupuncture vs Massage for Cancer Pain

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

300 Participants Needed

Trial Summary

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.

What data supports the effectiveness of acupuncture and massage as treatments for cancer pain?

Research suggests that acupuncture can be effective for managing pain and other symptoms in cancer patients, such as nausea and vomiting, and is recommended by organizations like the American Cancer Society. However, evidence for massage therapy's effectiveness in cancer pain is inconsistent, and more research is needed to confirm its benefits. ^{1 2 3 4 5}

Is acupuncture safe for humans?

Acupuncture is generally considered safe, with serious adverse events being rare. Minor issues like mild bruising, pain, or feeling faint can occur, but these are usually not severe. It's important to ensure that the practitioner is well-trained to minimize risks. ^{4 5 6 7 8}

How does acupuncture and massage for cancer pain differ from other treatments?

Acupuncture and massage for cancer pain are unique because they are non-drug therapies that focus on physical manipulation and stimulation of the body to relieve pain, unlike standard treatments that often involve medication or surgery. These therapies may offer a more holistic approach, potentially reducing side effects associated with conventional cancer pain treatments. ^{9 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to compare the long-term effectiveness of acupuncture versus massage in people living with advanced cancer. The study will test how the two approaches compare in helping people with pain and its related symptoms and improving quality of life.

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

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[Acupuncture in the treatment of symptoms of oncological diseases in the Western world]. [2014]

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

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

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Complementary and alternative medicine for cancer pain: an overview of systematic reviews. [2023]

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Safety of Acupuncture: Overview of Systematic Reviews. [2022]

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Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. [2021]

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Patient reported quality of life after helical IMRT based concurrent chemoradiation of locally advanced anal cancer. [2018]

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Requiem for Nigro or is anal squamous carcinoma still a surgical problem: Abdominoperineal excision rather than a defunctioning stoma? [2019]

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Toxicity and survival of anal cancer patients treated with intensity-modulated radiation therapy. [2020]

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

Long-Term Patient-Reported Quality of Life of Anal Cancer Survivors Treated With Intensity Modulated Radiation Therapy and Concurrent Chemotherapy: Results From a Prospective Phase II Trial. [2023]

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

Comparative Effectiveness Analysis of 3D-Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy (IMRT) in a Prospective Multicenter Cohort of Patients With Breast Cancer. [2023]