CancerFOCCUSNCT02121626
The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms"
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- How many people
- 248 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients aged less than 18 years
- Patients unable to give informed consent
- Patients being treated privately
- Patients on studies with conflicting end-points
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Neoplasms, Exocrine Pancreatic Insufficiency, Anorexia, Constipation, Diarrhea, Mucositis, Deglutition Disorders, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new onset GI symptoms per chemotherapy regimen
Measured: Every 4 weeks
Secondary outcomes (7)
Change in Gastrointestinal Symptom Rating Scale (GSRS) scores
Measured: Every 4 weeks
Change in Vaizey incontinence scores
Measured: Every 4 weeks
Change in Bristol Stool Chart parameters (stool frequency, type, mode)
Measured: Every 4 weeks
Change in Quality of Life scores (FACTG, version 4 questionnaires)
Measured: Every 4 weeks
Change in neurotoxicity scores (FACT/GOGNTX13, version 4)
Measured: Every 4 weeks
Competency (learning outcomes) GI research nurses
Measured: Every 2 months
Identification of genetic profiles which predispose to specific chemotherapy induced toxicities.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jervoise Andreyev, MBBS, Ph.D, Study chair, Royal Marsden NHS Foundation TrustLinda Wedlake, RD MSc BSc, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121626
- Sponsor's protocol ID
- CCR 3921
- Acronym
- FOCCUS
- Status last verified
- Nov 2017
- First submitted
- 17 Apr 2014
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32676853
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FOCCUS Study: "Focusing on Cancer Chemotherapys' Untreated Symptoms"
- ClinicalTrials.gov ID
- NCT02121626
- Acronym / sponsor ID
- FOCCUS / CCR 3921
- Conditions
- Cancer
- Keywords
- Cancer, Chemotheraphy, Small Bowel Bacterial Overgrowth, Bile Acid Malabsorption, Pancreatic Insufficiency, Carbohydrate Malabsorption, Anorexia, Borborygmi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients aged less than 18 years
- Patients unable to give informed consent
- Patients being treated privately
- Patients on studies with conflicting end-points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of new onset GI symptoms per chemotherapy regimen
Time frame: Every 4 weeks
7 secondary outcomes
Change in Gastrointestinal Symptom Rating Scale (GSRS) scores
Time frame: Every 4 weeks
Change in Vaizey incontinence scores
Time frame: Every 4 weeks
Change in Bristol Stool Chart parameters (stool frequency, type, mode)
Time frame: Every 4 weeks
Change in Quality of Life scores (FACTG, version 4 questionnaires)
Time frame: Every 4 weeks
Change in neurotoxicity scores (FACT/GOGNTX13, version 4)
Time frame: Every 4 weeks
Competency (learning outcomes) GI research nurses
Time frame: Every 2 months
Identification of genetic profiles which predispose to specific chemotherapy induced toxicities.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Derived from this study: PubMed 32676853Andreyev 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jervoise Andreyev, MBBS, Ph.D study chair
Royal Marsden NHS Foundation Trust
Linda Wedlake, RD MSc BSc principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new onset GI symptoms per chemotherapy regimen (time frame: Every 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.