Status:
ACTIVE_NOT_RECRUITING
Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Cancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04095234
Start Date
September 17 2019
End Date
September 1 2026
Last Update
October 10 2025
Active Locations (8)
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1
Baptist Alliance MCI
Miami, Florida, United States, 33143
2
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645