Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02121626
Study type Observational
Source Royal Marsden NHS Foundation Trust
Contact
Status Completed
Phase N/A
Start date April 2014
Completion date April 2017

See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases