Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer (NCT03927885) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer
United States100 participantsStarted 2019-03-30
Plain-language summary
This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.
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)
* Presence of fatigue of \>= 4/10 on Edmonton Symptom Assessment System (ESAS) Fatigue item (0-10 severity scale)
* Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
* Uncontrolled pain; 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. Change in opioid dose after study entry is allowed
* Patient must be 18 years of age or older. The questionnaires used in this study have been validated only in the adult population
* 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 \>= 8 g/dL. Patient may receive packed red blood cell (PRBC) transfusion so as to have hemoglobin level of \>= 8 g/dL so at participate in the study
Exclusion Criteria:
* Surgery, or pain relieving procedures within 2 weeks of entry into the study or during the study period
* Patients with history of substance abuse (Cut down, Annoyed, Guilty, Eye opener \[CAGE\] \>= 2+), cognitively impaired (MD Anderson Symptom \[MDAS\] \> 7)
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.