The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms" (FOCCUS)

November 21, 2017 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Chemotheraphy Treatement
The study will be limited to NHS patients to reduce complications associated with the need for additional funding authorisations from private health care providers for algorithm-instigated investigations. It is not envisaged that participation in other studies running within the GI unit at The Royal Marsden Hospital will preclude entry into this study except in the event of those rare studies where the study is specifically measuring toxicity of treatment as the primary end point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of new onset GI symptoms per chemotherapy regimen
Time Frame: Every 4 weeks
Every 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Gastrointestinal Symptom Rating Scale (GSRS) scores
Time Frame: Every 4 weeks
Every 4 weeks
Change in Vaizey incontinence scores
Time Frame: Every 4 weeks
Every 4 weeks
Change in Bristol Stool Chart parameters (stool frequency, type, mode)
Time Frame: Every 4 weeks
Every 4 weeks
Change in Quality of Life scores (FACTG, version 4 questionnaires)
Time Frame: Every 4 weeks
Every 4 weeks
Change in neurotoxicity scores (FACT/GOGNTX13, version 4)
Time Frame: Every 4 weeks
Every 4 weeks
Competency (learning outcomes) GI research nurses
Time Frame: Every 2 months
Every 2 months
Identification of genetic profiles which predispose to specific chemotherapy induced toxicities.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Study Chair: Jervoise Andreyev, MBBS, Ph.D, Royal Marsden NHS Foundation Trust
  • Principal Investigator: Linda Wedlake, RD MSc BSc, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCR 3921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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