Personalized Vitamin D Supplementation for Reducing or Preventing Fatigue and Enhancing Quality of Life of Patients with Colorectal Tumor: Randomized Intervention Trial (VICTORIA)
The VICTORIA study wants to find out if taking vitamin D supplements, specially chosen for you, can help lessen the feeling of extreme tiredness (fatigue) and make you feel better overall if you've had bowel cancer. It's for adults (18+) who have finished treatment for bowel cancer (like surgery, chemotherapy, or radiotherapy) in the last 12 months and have lower than ideal levels of vitamin D. Participants will either receive the vitamin D supplement or a dummy pill (placebo). The main aim is to see if the vitamin D group feels less tired after about 3-4 months compared to the placebo group.
At a glance
What is this study about?
Experiencing extreme tiredness, often called fatigue, is a very common and difficult problem for many people who have had bowel cancer. This tiredness can make every day feel like a struggle and can really affect your quality of life. Scientists believe there might be a link between how much vitamin D you have in your body and how tired you feel, especially after cancer treatments.
This study, called VICTORIA, is designed to carefully look at this connection. It aims to see if giving people with bowel cancer a personalised dose of vitamin D can help reduce their fatigue and improve their general well-being. A 'personalised' dose means the amount you receive might be adjusted based on your needs, rather than a one-size-fits-all approach.
The research is important because if vitamin D can indeed help with fatigue, it could offer a simple and effective way to improve the lives of people recovering from bowel cancer. This is a "Phase III" study, which means it's a large, important trial designed to confirm if a treatment works and is safe before it might be widely used.
Key takeaways
- This study investigates if vitamin D helps with tiredness after bowel cancer treatment.
- It's for adults (18+) who finished bowel cancer treatment within the last year.
- You must have low vitamin D levels to be eligible.
- You'll either receive vitamin D or a dummy pill (placebo).
- Participation involves taking capsules, clinic visits, blood tests, and questionnaires.
- The main focus is on reducing fatigue and improving quality of life.
Who may be eligible?
This study is looking for adults aged 18 years and older. You can participate whether you are male or female.
To be considered, you must have been diagnosed with bowel cancer (also known as colorectal cancer) and have finished your cancer treatment – this includes surgery, chemotherapy, or radiotherapy – within the last 12 months.
An important requirement is that you must also have lower than ideal levels of vitamin D in your blood. The research team will check your vitamin D levels to see if they are below a certain point (60 nmol/L). If your levels are good, you won't be able to join this particular study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with bowel cancer?
- Did you finish your bowel cancer treatment (surgery, chemo, or radiotherapy) in the last 12 months?
- Have you been told your vitamin D levels are lower than ideal (or are willing to have them checked)?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two groups: one group will receive a vitamin D capsule, and the other will receive a dummy capsule (called a placebo). You won't know which one you're getting, and neither will the research team, to ensure the results are fair.
You will need to take the capsule as instructed, and the study team will regularly check in with you. This will likely involve some clinic visits, blood tests to check your vitamin D levels, and filling in questionnaires about how tired you feel and your general quality of life. The main assessment to see if the treatment is working will happen around 13 to 16 weeks (about 3 to 4 months) after you start taking the capsules. The total duration of your involvement in the study will be explained by the research team.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is 'fatigue' in this study?
It means feeling unusually tired and lacking energy, even after rest, which can be common after cancer treatment.
What is vitamin D, and why is it important?
Vitamin D is a nutrient we get from sunlight and some foods. It's important for many body functions, including bone health and potentially energy levels.
Will I definitely get vitamin D if I join?
No, you have a 50/50 chance. You will either get vitamin D or a placebo (a dummy capsule) to compare the effects fairly.
How long will the study last for me?
The study will track your main results for about 3-4 months, but your total participation might be longer. The team will provide full details.
What does 'optimal vitamin D status' mean?
It refers to having enough vitamin D in your blood. This study is for people whose levels are lower than ideal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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