Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)
1 other identifier
interventional
300
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2019
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2019
CompletedStudy Start
First participant enrolled
September 17, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedOctober 10, 2025
October 1, 2025
3 years
September 17, 2019
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Acupuncture
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years or older
- Having a diagnosis of the following: stage III or IV lung cancer; any stage pancreatic cancer; unresectable cholangiocarcinoma; unresectable liver cancer; unresectable ampullary or peri-ampullary cancer or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer; stage IV genitourinary cancer; stage III or IV sarcoma; stage IV melanoma; stage III or IV head/neck cancer; stage IV endocrine cancer; or hematological malignancies (lymphoma, myeloma, and leukemia)
- Be ambulatory (Karnofsky functional score of ≥ 60)
- Having musculoskeletal pain, defined as regional (joints, extremities, back, neck) or more generalized (fibromyalgia or chronic widespread pain); Patients with a neuropathic component to their pain that involves the extremities or back will be eligible.
- Having musculoskeletal pain for at least 1 month
- Having had pain for at least 15 days in the preceding 30 days
- Having a pain rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week
- Having an expected prognosis of greater than six months as judged by the treating oncologist or study physician
You may not qualify if:
- Having a platelet count \<15,000
- Cognitive impairment precluding response to study assessments
- Unwilling to accept random assignment
- Unwilling to commit to the 26-week study time period
- Have non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) if these are the sole source of pain but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined as above.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Baptist Alliance MCI
Miami, Florida, 33143, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
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
Related Publications (3)
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.
PMID: 38977653DERIVEDEpstein 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.
PMID: 37962891DERIVEDRomero 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.
PMID: 36581960DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun J Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2019
First Posted
September 19, 2019
Study Start
September 17, 2019
Primary Completion
September 30, 2022
Study Completion (Estimated)
September 1, 2026
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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.