Three NIH studies will focus on fatigue
If you’re tired of being tired, you’re not alone. Cancer survivors, people with chronic illnesses such as lupus, and many older adults suffer from fatigue.
A lab at NIH’s National Institute of Nursing Research is currently enrolling people in three clinical trials related to fatigue.
“They’re all trying to better understand fatigue,” said Alex Ross, senior research nurse specialist at the National Institute of Nursing Research, who works in the laboratory of Dr. Leorey N. Saligan, principal investigator of the three studies. “We are trying to understand the entire fatigue experience.”
Seeking relief for chronic fatigue
In one study, which lasts one month, participants will record their fatigue levels on a questionnaire and then take several tests of their cognition, memory and motivation.
Then they’ll be given either ketamine (the study drug), a general anesthetic that has reduced fatigue in depressed people, or the sedative midazolam (the comparison drug), known as Versed. Previous studies have showed that general anaesthetics have reduced fatigue in depressed people. Both drugs will be given intravenously, two weeks apart.
Throughout the month, while enrolled in the study, study participants will wear a wristband device, which will record their physical activity. This will help determine if the interventions affect physical activity and sleep.
This study seeks cancer survivors age 18 to 70 who have been diagnosed with fatigue for at least six months or anyone diagnosed with chronic conditions such as chronic fatigue syndrome or autoimmune disorders such as lupus and Sjogren’s. (Some medications disqualify patients from the study, however.)
“We’ve seen positive results so far,” Ross said. “One patient reached out to [NIH Director] Francis Collins after one infusion, and he blogged about it. It was life-changing for him. Participants are finding some temporary symptom relief” from the study intervention, he said.
Personalized treatments
In another clinical trial, researchers will look at how fatigue affects people in different ways.
“We’re trying to find out if there are different types of fatigue,” Ross explained, which may require different treatments.
This study requires six to eight visits. Participants will undergo cognitive testing and an optional MRI.
They’ll also complete some motivational tasks and have their vital signs, such as blood pressure, recorded. Healthy volunteers will be recruited also to serve as the control group.
“At end of this study, we take all of this data and meet with the participants and offer them a one-time referral to a specific service within the [NIH] clinical center to help them manage their fatigue at home,” Ross said.
In effect, researchers will give a personalized assessment, he said. “They’ll say, ‘This is what we think will be most effective in getting you on the path to manage your fatigue.’”
Ross acknowledges that it may be difficult for people to complete all the in-person visits, so researchers are willing to be flexible. “We don’t want participants who are extremely fatigued to feel like this is overwhelming,” Ross said.
“We’ve really tried to make it so people can do things like the questionnaires at home. So, they can do it on their couch, relaxed and comfortable.”
For cancer patients only
The third study is open to cancer survivors or people undergoing cancer treatment.
“It’s important to understand how normal aging contributes to the experience of fatigue, especially in cancer patients,” Ross said.
The study requires up to three visits, which can be done entirely from home or in person.
After screening, patients will take cognitive tests, strength tests, and answer questionnaires. Dr. Saligan’s team will even travel to patients’ homes to draw blood.
Free parking and compensation may be available for these studies.
For more information about any of these clinical trials, call NIH’s patient recruitment center at 1-800-411-1222, (301) 451-4383 or email ccopr@nih.gov.