Effectiveness of Acupuncture versus Massage for Pain and Related Symptoms in Patients with Advanced Cancer, IMPACT Study
- 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
- 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
I. To compare the long-term effectiveness (26 weeks from randomization) of acupuncture versus massage for pain (primary outcome) and co-morbid symptoms (fatigue, sleep disturbance, and quality of life) in patients living with advanced cancer.
II. To identify patient-level demographic characteristics (e.g. sex, race, age), clinical factors (e.g. insomnia, pain severity), and psychological attributes (i.e. outcome expectation) that are associated with a greater reduction in pain for either acupuncture or massage.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo acupuncture over 30-60 minutes for up to 10 treatments in the first 10 weeks and then booster treatments monthly for up to 26 weeks.
GROUP II: Patients undergo massage over 30-60 minutes for up to 10 treatments in the first 10 weeks and then booster treatments monthly for up to 26 weeks.
Trial Phase Phase II
Trial Type Supportive care
Memorial Sloan Kettering Cancer Center
Jun J Mao
- Primary ID 19-341
- Secondary IDs NCI-2019-06604
- Clinicaltrials.gov ID NCT04095234