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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Cancer Pain

Treatments: Procedure: Massage; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04095234

19-341

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Acupuncture

Massage

Active Comparator group

Description:

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.

Treatment:

Procedure: Massage