Clinical trial NCT02121626: The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms"
Official title: The FOCCUS Study: "Focusing on Cancer Chemotherapys' Untreated Symptoms"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
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.
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or above able to give informed consent
* Patients referred to one of the five prescribing consultants described above
* Patients to be treated within the GI unit at the Royal Marsden Hospital (RMH Chelsea, Sutton or Kingston) with chemotherapy with or without other treatments.

Exclusion Criteria:

* Patients aged less than 18 years
* Patients unable to give informed consent
* Patients being treated privately
* Patients on studies with conflicting end-points

Primary outcomes:
measure: Incidence of new onset GI symptoms per chemotherapy regimen
timeFrame: Every 4 weeks
Secondary outcomes:
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS) scores
timeFrame: Every 4 weeks
measure: Change in Vaizey incontinence scores
timeFrame: Every 4 weeks
measure: Change in Bristol Stool Chart parameters (stool frequency, type, mode)
timeFrame: Every 4 weeks
measure: Change in Quality of Life scores (FACTG, version 4 questionnaires)
timeFrame: Every 4 weeks
measure: Change in neurotoxicity scores (FACT/GOGNTX13, version 4)
timeFrame: Every 4 weeks
measure: Competency (learning outcomes) GI research nurses
timeFrame: Every 2 months
measure: Identification of genetic profiles which predispose to specific chemotherapy induced toxicities.
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Jervoise Andreyev, MBBS, Ph.D
role: STUDY_CHAIR
affiliation: Royal Marsden NHS Foundation Trust
name: Linda Wedlake, RD MSc BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreyev HJN, Lalji A, Mohammed K, Muls ACG, Watkins D, Rao S, Starling N, Chau I, Cruse S, Pitkaaho V, Matthews J, Caley L, Pittordou V, Adams C, Wedlake L. The FOCCUS study: a prospective evaluation of the frequency, severity and treatable causes of gastrointestinal symptoms during and after chemotherapy. Support Care Cancer. 2021 Mar;29(3):1443-1453. doi: 10.1007/s00520-020-05610-x. Epub 2020 Jul 16.