Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Rela… (NCT03035409) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors
United States129 participantsStarted 2017-02-08
Plain-language summary
This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
* Presence of fatigue on FACIT-F subscale of =\< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
* Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
* CRP must be \>= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
* No evidence of moderate to severe depression as determined by a HADS depression score of =\< 13
* Presence of unintentional weight loss ranging from \>= 2 - =\< 15% in last 12 months
* Uncontrolled pain; if patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (\> 25%) for at least 48 hours prior to study entry; the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by the principal investigator (PI); change in opioid dose after study entry is allowed
* Patient must be willing to engage in telephone follow up with research staff
* Patient must have telephone access to be contacted by the research staff
* Hemoglobin level of \>= 9 g/dL
* Estimated life expectancy of \> 4 months at the time of screening
* Aspartate transaminase (AST) and alanine transaminase (ALT) levels =\< 5 x upper limit of normal (ULN)
Exclusion Criteria:
* Major contraindications to anamorelin e.g. hypersensitivity
* Regularly engaged in moder…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)