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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2026-09-30

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.

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Detailed Description

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Conditions

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Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm parallel (Acupuncture vs. Massage) randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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.

Massage

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.

Group Type ACTIVE_COMPARATOR

Massage

Intervention Type PROCEDURE

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.

Interventions

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Acupuncture

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.

Intervention Type PROCEDURE

Massage

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No