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

NCT02121626 | Completed DMC

• 1 other identifier: CCR 3921
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (1)

• Incidence of new onset GI symptoms per chemotherapy regimen

  Every 4 weeks

Secondary Outcomes (7)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) scores

  Every 4 weeks

• Change in Vaizey incontinence scores

  Every 4 weeks

• Change in Bristol Stool Chart parameters (stool frequency, type, mode)

  Every 4 weeks

• Change in Quality of Life scores (FACTG, version 4 questionnaires)

  Every 4 weeks

• Change in neurotoxicity scores (FACT/GOGNTX13, version 4)

  Every 4 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32676853 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Stool Samples will be collected for translational analysis.

MeSH Terms

Conditions

Neoplasms; Exocrine Pancreatic Insufficiency; Anorexia; Constipation; Diarrhea; Mucositis; Deglutition Disorders; Nausea; Pain; Gastroesophageal Reflux; Steatorrhea; Vomiting; Weight Loss; Flatulence

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Mouth Diseases; Stomatognathic Diseases; Esophageal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Esophageal Motility Disorders; Malabsorption Syndromes; Intestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight

Study Officials

• Jervoise Andreyev, MBBS, Ph.D

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

• Linda Wedlake, RD MSc BSc

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: April 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

GB (1)