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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095234
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cancer Pain Procedure: Acupuncture Procedure: Massage Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm parallel (Acupuncture vs. Massage) randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Worst Pain [ Time Frame: 26 weeks from randomization ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 IV genitourinary cancer; stage III or IV sarcoma; stage IV melanoma; stage III or IV head/neck cancer; or stage IV endocrine cancer
  • 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:

  • 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.
  • Having an implanted electronically charged medical device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095234


Contacts
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Contact: Jun J Mao, MD, MSCE 646-888-0866 maoj@mskcc.org
Contact: Gary Deng, MD, PhD 646-888-0841

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jun J Mao, MD,MSCE    646-888-0808      
Contact: Gary Deng, MD, PhD    646-888-0841      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jun J Mao, MD, MSCE Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04095234    
Other Study ID Numbers: 19-341
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
acupuncture
massage
IMPACT
19-341
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms