Effectiveness of Acupuncture versus Massage for Pain and Related Symptoms in Patients with Advanced Cancer, IMPACT Study

Status: Active

Description

This phase II trial compares the long-term effectiveness of acupuncture versus massage for the treatment of pain in patients with cancer that has spread to other places in the body (advanced). Pain is one of the most commonly reported symptoms among individuals with advanced cancer, and it has been linked to other symptoms, such as tiredness (fatigue), trouble sleeping (sleep disturbances), and a decrease in quality of life. Acupuncture is a traditional Chinese medicine that involves penetrating the skin with very thin, solid, metallic needles that are moved by hand or by electrical stimulation, which may cause the brain to produce chemicals that provide pain relief. Massage therapy techniques promote joint flexibility, relieve muscular tension, and improve range of motion, which may reduce pain in targeted areas. 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

  • 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 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

  • Receiving anticoagulant therapy
  • 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

Locations & Contacts

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0866

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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 weekly acupuncture treatment over 30-60 minutes for 10 weeks, then monthly for up to 26 weeks.

GROUP II: Patients undergo weekly massage treatment over 30-60 minutes for 10 weeks then, monthly for up to 26 weeks.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Supportive care

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Jun J Mao

Trial IDs

Primary ID 19-341
Secondary IDs NCI-2019-06604
Clinicaltrials.gov ID NCT04095234