Clinical trial NCT04095234: Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)
Official title: Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer Pain
Keywords: acupuncture
massage
IMPACT
19-341
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel (Acupuncture vs. Massage) randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility 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 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:

* 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.

Primary outcomes:
measure: Worst Pain
timeFrame: 26 weeks from randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Alliance MCI
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun J Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: