Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT04095234
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04095234
Study Brief:
Protocol Section:
NCT04095234