A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunothe… (NCT03525873) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy
United States212 participantsStarted 2018-08-02
Plain-language summary
This phase III trial studies how well methylphenidate and physical activity works in reducing cancer-related fatigue in patients who are receiving anti-PD1 immunotherapy for cancer that has spread to other places in the body. Central nervous systems stimulants, such as methylphenidate, may help to improve cognitive function. Physical activity uses techniques, such as aerobic and resistance exercises, which may help to improve quality of life. Giving methylphenidate and physical activity may help in reducing cancer-related fatigue in patients with metastatic cancer who receive anti-PD1 immunotherapy.
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:
* Part 1: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment
* Part 1: be willing to engage in follow-up telephone calls with a research staff
* Part 1: have telephone access so they can be contacted by the research staff
* Part 1: hemoglobin level of \>= 8 g/dL within 2 weeks of enrollment
\* Packed red blood cell (PRBC) transfusions will be allowed to patients with hemoglobin \< 8 g/dl
* Part 1: be able to understand the description of the study and give written informed consent
* Part 1: able to read, write and speak English
* Part 2: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment
* Part 2: be willing to engage in follow-up telephone calls with a research staff
* Part 2: have telephone access so they can be contacted by the research staff
* Part 2: have a hemoglobin level of \>=8 g/dL within 2 weeks of enrollment
\* PRBC transfusions will be allowed to patients with hemoglobin \< 8 g/dl
* Part 2: be able to understand the description of the study and give written or verbal informed consent
* Part 2: able to read, write and speak English
* Part 2: presence of fatigue as defined FACIT-F subscale of =\< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
* Part 2: not currently taking met…
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
Assessment of the effects of methylphenidate (MP) plus physical activity in reducing cancer-related fatigue (CRF)