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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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. |
|
| Massage | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Acupuncture, a therapy of traditional Chinese medicine (TCM), involves penetrating the skin with thin, solid, metallic needles that are manipulated by hand or electrical stimulation. If the patient has an electronically charged device, they will not receive TENS stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Pain | Worst Pain Item from the short-form Brief Pain Inventory (BPI). The short-form BPI will be used to quantify pain severity and pain interference. The BPI contains 4 pain severity items and 7 pain interference items, all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference). | 26 weeks from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun J Mao, MD, MSCE | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Alliance MCI | Miami | Florida | 33143 | United States | ||
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38977653 | Derived | Booher A, Mao JJ, Muniz RC, Romero SAD, Li SQ, Lopez AM, Liou KT. Association between Hispanic Ethnicity and Greater Expectation of Benefit from Acupuncture or Massage for Pain in Cancer. J Immigr Minor Health. 2024 Oct;26(5):953-957. doi: 10.1007/s10903-024-01611-8. Epub 2024 Jul 8. | |
| 37962891 | Derived | Epstein AS, Liou KT, Romero SAD, Baser RE, Wong G, Xiao H, Mo Z, Walker D, MacLeod J, Li Q, Barton-Burke M, Deng GE, Panageas KS, Farrar JT, Mao JJ. Acupuncture vs Massage for Pain in Patients Living With Advanced Cancer: The IMPACT Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342482. doi: 10.1001/jamanetworkopen.2023.42482. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D008405 | Massage |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
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Two-arm parallel (Acupuncture vs. Massage) randomized controlled trial
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|
| Massage | Procedure | Massage, which involves the manual manipulation of muscles and other soft tissue areas of the body, is one of the earliest known forms of pain relief. |
|
| Basking Ridge |
| New Jersey |
| 07920 |
| United States |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (All Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Uniondale | New York | 11553 | United States |
| 36581960 | Derived | Romero SAD, Emard N, Baser RE, Panageas K, MacLeod J, Walker D, Barton-Burke M, Liou K, Deng G, Farrar J, Xiao H, Mao JJ, Epstein A. Acupuncture versus massage for pain in patients living with advanced cancer: a protocol for the IMPACT randomised clinical trial. BMJ Open. 2022 Sep 1;12(9):e058281. doi: 10.1136/bmjopen-2021-058281. |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |