Cancer Clinical Trial
Official title:
The FOCCUS Study: "Focusing on Cancer Chemotherapys' Untreated Symptoms"
The aim of the study is to identify how often gastrointestinal problems interfere with quality of life as a result of treatment for cancer with chemotherapy. We also want to identify the causes for these symptoms and see if simple treatments used for other gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently, it can cause a whole range of physical side effects. Probably the most common side effects are those affecting the stomach and bowels. Vomiting used to be a major problem with chemotherapy but research discovered a whole series of new treatments so that severe vomiting from chemotherapy is rarely a problem today. However, patients can develop a whole series of other symptoms during chemotherapy, for example, bloating, wind, diarrhoea, needing to rush to the lavatory and opening the bowels very frequently. The causes for these symptoms have hardly been studied even though they sometimes affect people quite badly. In our specialist gastrointestinal clinic at the Royal Marsden Hospital, over the last 12 years, we have pioneered new methods for dealing with symptoms which affect the bowel after radiotherapy. We would like to extend these methods to people having chemotherapy. We have identified several easily treatable causes for these symptoms after radiotherapy, which previously were often ignored. We believe that some of these causes also occur in people having chemotherapy and if we knew how often they do occur we could focus on improving treatment for affected people. We plan to find out how often 40 stomach and bowel symptoms occur during chemotherapy. In people who are troubled by any or some of these symptoms we will arrange simple series tests which could sort out why these symptoms occur and we will record how they respond to treatment.
Chemotherapy (CT) remains an integral part of treatment for many types of cancer often in
combination with surgery and/or radiotherapy. In the year March 2011 to April 2012, 1807
patients were referred to the Royal Marsden Hospital (RMH) Gastrointestinal Unit with a new
gastro intestinal (GI) cancer of whom 709 were treated with chemotherapy alone or in
combination with other long term outcome. GI symptoms are common in patients receiving
chemotherapy. They may arise from the tumour, but may also result as a side effect of
treatment. They include anorexia, borborygmi, bloating, constipation, diarrhoea, dysphagia,
early satiety, frequency of defaecation, incontinence, mucus discharge, nausea, nocturnal
defaecation, pain, reflux, regurgitation, steatorrhoea, tenesmus, urgency of defaecation,
vomiting, weight loss and wind. Frequently, such symptoms have a significant impact on
patients' quality of life. They may also interfere with the delivery of treatment prompting
cessation of therapy or dose reduction resulting in sub optimal dosage with a potential
impact on morbidity and mortality. Whilst clinicians have long focused on the management of
vomiting and pain in cancer patients, less attention has been paid to the incidence, severity
or optimal management of other GI symptoms. If the cause of these symptoms can be identified,
then appropriate investigations and treatments can be prescribed. The GI Unit has
successfully investigated and treated patients with symptoms emerging after radiotherapy.
This experience has enabled the team to develop an algorithm for facilitating the
investigation and treatment of cancer therapy induced symptoms. The algorithm has recently
been shown to be effective in the management of patients with radiation induced bowel injury
. In particular, it enables the rapid identification of required investigations and improves
the management of symptoms that might otherwise be mislabeled as inevitable consequences of
treatment. Five easily treatable causes for GI symptoms have so far been identified:
- Small bowel bacterial overgrowth
- Carbohydrate malabsorption
- Bile acid malabsorption
- Gastric bile reflux
- Pancreatic insufficiency
It is likely that additional causes such as viral infections (eg cytomegalovirus) are more
frequent in patients undergoing chemotherapy than currently appreciated.
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