CClinicalTrials.gg
Active, not recruitingNCT04095234Updated Oct 10, 2025

Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)

A Phase 2 interventional study of Acupuncture and Massage in Cancer Pain, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer Pain

Keywords

  • acupuncture
  • massage
  • IMPACT
  • 19-341
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Acupuncture

    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.

    Procedure: Acupuncture

  • Active comparator
    Massage

    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.

    Procedure: Massage

Interventions

  • ProcedureAcupuncture

    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.

  • ProcedureMassage

    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.

05

What researchers measure

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).

    Time frame: 26 weeks from randomization

06

Study locations

8 sites
  • 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
07

References and documents

Publications

  • 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. PubMed 38977653 ↗
  • 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. PubMed 37962891 ↗
  • 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. PubMed 36581960 ↗

Individual participant data

Plan to share: Yes — 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.

08

Registry details

Key details

Study ID
NCT04095234
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Sep 19, 2019
Start date
Sep 17, 2019
Primary completion
Sep 30, 2022
Completion
Sep 2026 (estimated)
Last update
Oct 10, 2025

Study contacts

Jun J Mao, MD, MSCE
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion