The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms"
Condition: Cancer
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at The Royal Marsden NHS Foundation Trust who have been diagnosed with cancer and
        are receiving chemotherapy as part of their treatment. This study will recruit men and
        women who will receive chemotherapy for cancers of the oesophagus, stomach, pancreas,
        liver, biliary tree or bowel.
      
Biospecimen description: 
      Blood and Stool Samples will be collected for translational analysis.
    
Keywords: Cancer; Chemotheraphy; Small Bowel Bacterial Overgrowth; Bile Acid Malabsorption; Pancreatic Insufficiency; Carbohydrate Malabsorption; Anorexia; Borborygmi; Bloating; Constipation; Diarrhoea; Mucositis; Dysphagia; Early satiety; Frequency of defaecation; Incontinence; Mucus discharge; Nausea; Nocturnal defaecation; Pain; Reflux; Regurgitation; Steatorrhoea; Tenesmus; Urgency of defaecation; Vomiting; Weight loss; Wind.