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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer Pain

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Massage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm parallel (Acupuncture vs. Massage) randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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. | Procedure: Acupuncture<br>* Acupuncture, a therapy of traditional Chinese medicine (TCM), involves penetrating the skin with thin, solid, metallic needles that are manipulated by hand or electrical stimulation. If the patient has an electronically charged device, they will not receive TENS stimulation.<br>|
| Active Comparator: Massage<br>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. | Procedure: Massage<br>* Massage, which involves the manual manipulation of muscles and other soft tissue areas of the body, is one of the earliest known forms of pain relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst Pain | Worst Pain Item from the short-form Brief Pain Inventory (BPI). The short-form BPI will be used to quantify pain severity and pain interference. The BPI contains 4 pain severity items and 7 pain interference items, all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference). | 26 weeks from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, massage, IMPACT, 19-341