A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer (RECITE)
This research study, called RECITE, is investigating a new medication called Romiplostim (also known as Nplate) for people undergoing chemotherapy for stomach, bowel, or pancreatic cancer. Chemotherapy can sometimes lead to a side effect called thrombocytopenia, where there aren't enough tiny blood cells called platelets. Platelets are crucial for helping blood to clot and stop bleeding. If platelet levels drop too low, it can mean chemotherapy treatments have to be postponed, given in smaller doses, or even stopped. This study is trying to find out if Romiplostim can help keep platelet counts stable during chemotherapy. Half the participants will receive Romiplostim and the other half a dummy medicine (placebo) to see if the new medicine makes a difference.
At a glance
What is this study about?
When people are treated for cancers like those in the stomach, bowel, or pancreas with chemotherapy, a common side effect can be that their body doesn't produce enough platelets. Platelets are extremely important because they are the tiny blood cells that help your blood clot, which stops bleeding and bruising. When platelet counts get too low, doctors might have to change the chemotherapy plan – for example, giving a smaller dose, delaying the next treatment, or even pausing it altogether. This can be upsetting and may affect how well the cancer treatment works.
This study, named RECITE, is trying to find a better way to manage this problem. It's looking at a medicine called Romiplostim (you might also hear it called Nplate). Romiplostim is designed to encourage your body to make more platelets. The main goal is to see if taking Romiplostim can help prevent those platelet drops that force changes to chemotherapy, especially during the second and third cycles of treatment. This means people could potentially get their chemotherapy as planned, which is a major benefit.
The study is comparing Romiplostim to a 'placebo', which looks exactly like the actual medicine but doesn't contain any active drug. This is a common way to test new medicines fairly, so researchers can be sure any effects they see are truly due to Romiplostim and not just chance. Researchers will be carefully monitoring platelet levels, any bleeding events, and overall health to understand how well Romiplostim works and if it's safe.
Key takeaways
- This study is for people with certain cancers receiving chemotherapy.
- It aims to prevent low platelet counts caused by chemotherapy.
- The new medicine, Romiplostim, encourages the body to make more platelets.
- Participants will receive either Romiplostim or a dummy medicine (placebo).
- The main goal is to help ensure chemotherapy can be given as planned.
- Regular health checks and blood tests will be part of the study.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women can take part. It's important that you have been diagnosed with cancer of the stomach, pancreas, or bowel.
Also, you need to be currently receiving chemotherapy treatment that includes a medicine called oxaliplatin. This study is specifically for people whose low platelet counts are a result of this chemotherapy. Your doctors will check if you meet all the specific medical requirements for the study.
Beyond these general points, there will be other health checks and conditions that the study doctors will go through with you to make sure the study is right and safe for you.
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?
- Do you have stomach, pancreatic, or bowel cancer?
- Are you currently receiving chemotherapy that includes the drug oxaliplatin?
- Has your doctor told you that your low platelet levels are due to your chemotherapy?
- Are you able to attend regular clinic appointments for injections and checks?
What does participation involve?
If you decide to take part in this study, you would be assigned to either receive the study medicine, Romiplostim, or a dummy medicine (placebo). Neither you nor your study doctor would know which one you are receiving – this is to ensure the results are fair and unbiased. Both are given as an injection, and the doses are carefully measured.
You would continue to receive your planned chemotherapy. Throughout the study, you would have regular visits to the clinic. These visits would involve blood tests to check your platelet counts and other health markers, and doctors would monitor you closely for any side effects. You would also report any new symptoms or issues you experience.
The study will focus on your health during your chemotherapy cycles, particularly the second and third. We would also track your overall health for a longer period. The total duration of your participation will depend on your chemotherapy plan and a follow-up period, and the study team will explain this fully if you are interested.
Potential risks and benefits
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Common questions
What are platelets and why are they important?
Platelets are tiny cells in your blood that help it clot and stop bleeding. Having enough platelets is vital to prevent easy bruising or bleeding.
What does 'chemotherapy-induced thrombocytopenia' mean?
This means your platelet count is too low because of your chemotherapy treatment. Thrombocytopenia is the medical term for low platelets.
What is Romiplostim?
Romiplostim is a medicine designed to help your body make more platelets.
What is a 'placebo'?
A placebo is a dummy medicine that looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.
Will I know if I'm getting the study medicine or the placebo?
No, neither you nor your study doctor will know. This is called a 'double-blind' study and ensures the results are as accurate as possible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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