Treatment Every 2 Weeks or Every 3 Weeks for Non-Hodgkin Lymphoma (r-CHOP 14 Versus r-CHOP 21) Introduction Diffuse large B cell lymphoma is a type of Non Hodgkin lymphoma. The recommended treatment for this disease is a combination of chemotherapy drugs which are commonly known as R-CHOP. The drugs which make up R-CHOP are R= Rituximab C=
Hydroxydaunorubicin (also known as doxorubicin, daunorubicin but more commonly known as adriamycin)
O= Oncovin (more commonly known as vincristine) P=
What is the aim of this trial? This trial aims to find out whether having R-CHOP every 2 weeks is more effective than having R-CHOP every 3 weeks in the treatment of people with newly diagnosed diffuse large B cell lymphoma. Who can enter this trial? You may be asked to enter this trial if you meet the following criteria: You are aged 18 or over You have a confirmed diagnosis of diffuse large B cell non Hodgkin lymphoma You have had no previous chemotherapy, radiotherapy or other treatment for this disease. Your blood test results are okay You have no serious heart conditions You are not pregnant You have not had chemotherapy in the past. If you are of child bearing age you must agree to use barrier contraception such as condoms during and after the trial for six months. What might stop me from entering this trial? You won’t be asked to enter this trial for the following reasons: You have had another type of non Hodgkin lymphoma such as T cell lymphoma or transformed follicular lymphoma. You have lymphoma in your brain or spinal cord You have a past history of heart failure or angina You are not well enough to have the chemotherapy If you have had cancer in the last ten years, apart from non-melanoma skin cancer or in situ carcinoma of the cervix. You have any other serious medical condition. Do I have to take part? No. You are a key member of the health care team and it is completely up to you whether you want to be involved in this trial. You have a right to say no or withdraw at any time without your ongoing care or treatment being affected. If you do choose to take part you will be given lots of information and asked to sign a consent form. How is this trial run? This trial is known as a randomised control trial. A randomised control trial is a trial in which patients with similar disease traits are selected by a computer to be placed in different groups that are comparing different treatments. There is no way at the time for researchers to know which of the treatments is best and neither you nor your doctor get to choose which treatment you have. In this particular trial there are two groups. Regardless of which group you are in this treatment is usually given through outpatient visits unless you need to stay in the hospital for some reason. The first group has the standard treatment of R-CHOP 21. In this group you will have cyclophosphamide, adriamycin, vincristine and rituximab through a drip into your vein once every 3 weeks (21 days). The prednisolone is taken as a tablet once a day for five days out of the three weeks. Each period of 3 weeks is called a cycle. In total you will have 8 cycles. The second group has the treatment of R-CHOP 14. In this group you will have cyclophosphamide, adriamycin, vincristine and rituximab through a drip into your vein once every 2 weeks (14 days). The prednisolone is taken as a tablet once a day for five days out of the two weeks. Each period of 2 weeks is called a cycle. In total you will have 6 cycles of these drugs with 2 extra doses of rituximab. The chemotherapy drugs given in this trial can cause your blood cell count to drop which could make you more prone to infection. This is especially so if you are in the second group as you have less time than the first group for your blood cells to recover between cycles. To help support your blood cell recovery those in the second group will be given an injection of a drug called G-CSF. G-CSF encourages your blood cells to grow faster than normal. The drug is given as an injection just under the skin every day for 9 days during your 2 week cycle (if you count the day you have chemotherapy as day 1 then you will have the G-CSF on days 4-12). The chemotherapy nurses will teach you how to give this injection at home or will arrange for a district nurse to give it to you. Regardless of which group you are in you will have a blood test before each treatment and a number of tests done after four cycles. This is to determine how well the treatment is working for you. If it is working well and you can manage the side- effects you may have up to eight cycles in the first group or six cycles in the second group. If the treatment is not working so well or the side effects are severe your doctor may stop the treatment. What might being entered in this trial mean to me? Tests and hospital visits Before you enter the trial you will have a number of tests to see how wide spread your disease is. The investigations may include: A CT scan A heart test called an ECG Blood tests Bone marrow biopsy Physical examination On completion of your treatment you will be seen by your doctor every three months for a year, then every six months for a year. After this schedule of appointments is complete the doctor will see you once a year. Side effects As with other treatments there are some side effects which you should know about. Your doctor or nurse can give you much more detailed information on these effects and how you might manage them.
Cyclophospahide, adriamycin and vincristine have a few side effects but the most common are: Reducing your blood cell count which can make you more at risk of infection, or bleeding or feeling breath-less and tired. The drugs can make you feel sick. You may lose your appetite You may lose your hair but it will grow back some time after the treatment has ended. The vincristine can cause a tingling or numb feeling in your hands and feet Rituximab has a few side effects which tend to happen during the actual treatment or very soon afterwards. These may include: Chills and fever Headache A rash which might become itchy It can sometimes make you feel sick. Because prednisolone is a steroid it also has side effects such as: Mood changes Difficulty sleeping Tummy upsets
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