The primary objective is to test the hypothesis that an association between common genetic
variations, reported by SNPs in relevant candidate genes, is associated with individual patient
variability in normal tissue radiation response and toxicity. To this end, the following normal
tissue toxicity scoring will be obtained from all patients:
- LENT SOMA score
• Venous blood sample for SNP analysis.
A randomised placebo-controlled trial of synchronous NIMorazole versus RADiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma not suitable for synchronous chemotherapy or cetuximab
Patients who have had radiotherapy to the head and neck region often have problems with swallowing or mouth opening. These problems may make it difficult to eat certain foods. Some patients are unable to eat enough and have to be fed through a tube. High doses of radiation can also decrease the blood supply to the jawbone. If this happens, the bone gets less oxygen than it needs, which may result in the death of bone tissue. This relatively rare condition is called osteoradionecrosis or ORN. All of these problems can have a negative impact on patients’ quality of life.
Research suggests that one or more genes may be linked to the risk of post-radiation complications in the head and neck. We have already studied one gene and found that patients with one variation of the gene had an increased risk of ORN.
In this study we want to test a much larger collection of genes. We want to find out whether we can predict swallowing and mouth opening problems.
DNA is a chemical that contains the genetic instructions needed for a plant or animal to develop, survive and reproduce. DNA provides a unique genetic fingerprint for each person. Nearly every cell in a person’s body has the same DNA. Genetic tests are done using DNA that has been extracted from a sample of blood or saliva. The tests allow researchers to see which genes are more frequently present amongst those patients with severe complications and/or which genes are present amongst patients with fewer problems.
We will compare the genes from 2 groups of patients:
- 100 patients with few problems – the control group
- 100 patients who have severe complications – the radiosensitive group
|Thyroid cancer is the most common endocrine cancer, and while radioactive iodine therapy is an effective treatment for many patients, some patients will develop a thyroid cancer that does not take up iodine (iodinerefractory disease).
This condition carries a much poorer prognosis with few 10 year survivors.
While some multitarget tyrosine kinase inhibitors have proved effective in reducing the rate of progression in suchiodinerefractorytumours, these drugs must be taken continuously to provide benefit, and these treatment regimenshave significant and unpleasant side effect.
Selumetinib, a MEK inhibitor, has been shown in a previous pilot study to be able to induce iodine uptake in previouslyiodine refractory thyroid cancers following a short, 4 week, course of treatment
This study is designed to determine the proportion of patients in which treatment with Selumetinib increases theamount of iodine taken up by the previously iodinerefractorythyroid cancers following a short course (4 weeks) of the
drug. If significant increase in iodine uptake is seen, patients will receive further radioactive iodine therapy. Patients will then be followed up to determine whether this strategy impacts progression free survival.
This research is about measuring the impact of cancer and its treatment on patients and their informal caregivers (e.g. spouse, partner, family member, close friend). Having cancer can affect many aspects of life such as finances, work status and patients’ own caring roles with family or friends, which are important to understand but are not well captured by existing measures.
In studies 1-3 of PROACT we developed and evaluated two questionnaires measuring impact on caregiving and other responsibilities and lifestyle disruption for patients and caregivers. We developed the questionnaires through qualitative interview studies and through collaboration with advisors with lived experience of cancer or caring for someone with cancer. We then conducted some research to determine the reliability and validity of the new measures.
These comparisons are important to ensure that when health care professionals and researchers use our questionnaires, they can be confident that they are measuring wellbeing and impact with a reliable measure. Both
questionnaires performed well in this initial evaluation. In this fourth study we wish to repeat the evaluation with a new group of patients and caregivers. We will expand our inclusion criteria to include different types and stages of cancer. We will use the same methodology as study 3 and invite participants to complete the new PROACT measures three times over two months, along with other quality of life questionnaires at two of these time points. This enables us to see how our new measures perform over time; whether they are reliable if completed twice close together and whether they are able to detect change in wellbeing if completed two months apart in participants whose situations are changing. This next stage in validation is essential to ensure that the questionnaires are suitable for use in future research and practice across different types of cancer.