Cancer Clinical Trial
— FOCCUSOfficial title:
The FOCCUS Study: "Focusing on Cancer Chemotherapys' Untreated Symptoms"
Verified date | November 2017 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 248 |
Est. completion date | April 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of new onset GI symptoms per chemotherapy regimen | Every 4 weeks | ||
Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) scores | Every 4 weeks | ||
Secondary | Change in Vaizey incontinence scores | Every 4 weeks | ||
Secondary | Change in Bristol Stool Chart parameters (stool frequency, type, mode) | Every 4 weeks | ||
Secondary | Change in Quality of Life scores (FACTG, version 4 questionnaires) | Every 4 weeks | ||
Secondary | Change in neurotoxicity scores (FACT/GOGNTX13, version 4) | Every 4 weeks | ||
Secondary | Competency (learning outcomes) GI research nurses | Every 2 months | ||
Secondary | Identification of genetic profiles which predispose to specific chemotherapy induced toxicities. | 1 year |
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