In short
Two clinical trials are currently investigating different approaches to managing cancer-related fatigue. One study focuses on childhood brain tumor survivors in Denmark, testing methylphenidate, while another examines vitamin D3 supplementation for colorectal cancer patients in Germany who have completed treatment.
Clinical trial locations
- Denmark
- Germany
Study on Methylphenidate for Reducing Fatigue in Childhood Brain Tumor Survivors
This clinical trial is investigating whether methylphenidate can help reduce persistent tiredness in individuals who were treated for a brain tumor during childhood or adolescence. Methylphenidate is a medication commonly used to treat attention deficit hyperactivity disorder (ADHD), and researchers want to see if it can also help manage cancer-related fatigue.
Who can participate: The study is looking for participants who were diagnosed and treated for a brain tumor before the age of 18, with treatment having occurred within the last 10 years. Participants must be at least 6 years old and have been off active treatment for at least 12 months. They must have no signs of tumor progression and must speak Danish as their primary language. Importantly, participants need to experience significant fatigue as measured by a specific questionnaire, with tiredness levels noticeably higher than average.
Who cannot participate: Individuals who do not have cancer-related fatigue following brain tumor treatment are not eligible. Those outside the specified age range or who have not been confirmed through screening to have cancer-related fatigue cannot join. The study also excludes vulnerable populations who may require special protection.
What the trial involves: This is a crossover study, meaning participants will receive both methylphenidate and a placebo at different times during the trial. Neither the participants nor the researchers will know which treatment is being given at any particular time. Each treatment phase lasts six weeks, and participants will be monitored for changes in fatigue levels, attention, memory, and quality of life. The design allows researchers to directly compare the effects of the medication against the placebo in the same individuals.
Investigational drug: Methylphenidate is the medication being tested. It works by increasing levels of certain brain chemicals called dopamine and norepinephrine, which may help improve energy levels and attention. It is taken orally as tablets or capsules.
Study on Vitamin D3 and Glycerol for Reducing Fatigue in Colorectal Cancer Patients with Low Vitamin D Levels After Treatment
The VICTORIA trial is examining whether personalized vitamin D3 supplementation can reduce fatigue in patients who have completed treatment for colorectal cancer. Colorectal cancer affects the colon or rectum, and fatigue is a common problem for patients who have undergone surgery, chemotherapy, or radiation therapy.
Who can participate: The study is open to adults aged 18 and older who have been treated for colorectal cancer within the past 12 months. Participants must have low vitamin D levels (below 60 nmol/L) and plan to undergo at least three weeks of inpatient rehabilitation at a participating clinic. They must also be able to understand German well enough to comprehend the study requirements and provide informed consent.
Who cannot participate: Patients who do not experience fatigue related to their colorectal cancer treatment are excluded. Those who have not received colorectal cancer therapy in the last 12 months or who already have optimal vitamin D levels (60 nmol/L or higher) cannot participate. The study also excludes individuals outside the specified age range and vulnerable populations.
What the trial involves: This is a randomized trial lasting 12 weeks. Participants are randomly assigned to receive either personalized doses of vitamin D3 or a placebo capsule. Throughout the study, researchers will monitor changes in fatigue levels and overall quality of life. Regular assessments help track progress and ensure participant safety. At the end of the study, the difference in fatigue levels between the two groups will be evaluated to determine if vitamin D3 supplementation is effective.
Investigational drug: Vitamin D3 (colecalciferol) is being tested in personalized doses. This vitamin plays an important role in bone health and immune system function. It works by regulating calcium and phosphate balance in the body. The medication is taken orally as capsules or tablets.
Summary
These two trials represent different approaches to addressing cancer-related fatigue in distinct patient populations. The Danish study focuses on survivors of childhood brain tumors using a stimulant medication, while the German study targets colorectal cancer patients with a nutritional intervention. Both studies use placebo-controlled designs to ensure reliable results. The trials are geographically separated, with one taking place in Denmark and the other in Germany, each addressing fatigue management in their respective cancer survivor populations. These studies highlight the ongoing efforts to find effective treatments for cancer-related fatigue, a condition that significantly impacts quality of life for cancer survivors.
