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Cancer | The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms"

Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Chemotheraphy TreatementThe 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.

Study Status

Completed

Start Date: April 2014

Completed Date: April 2017

Phase:

Type: Observational

Design:

Primary Outcome: Incidence of new onset GI symptoms per chemotherapy regimen

Secondary Outcome: Change in Gastrointestinal Symptom Rating Scale (GSRS) scores

Study sponsors, principal investigator, and references

Principal Investigator: Jervoise Andreyev, MBBS, Ph.D

Lead Sponsor: Royal Marsden NHS Foundation Trust

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02121626

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