BOUNCED: are cancer patients diagnosed with partial bowel obstruction able to follow a 4 stage diet and does it reduce symptoms and improve quality of life?

Not Applicable

Completed

• Conditions: Bowel obstruction as a result of colorectal or ovarian cancer; Cancer

• Registration Number: ISRCTN10518796
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Study Completion: 2022-11-02
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Current inclusion criteria as of 14/12/2022:
1. Aged =18 years
2. Able to tolerate the oral diet
3. Diagnosis of colorectal cancer with a primary tumour in situ, locally advanced disease or peritoneal spread causing clinical symptoms of bowel obstruction OR diagnosis of gynaecological cancer with spread to the peritoneum causing clinical symptoms of bowel obstruction
4. Bowel obstruction considered inoperable at the time of consent
5. Presenting with any of the following clinical symptoms of sub-acute bowel obstruction:
5.1. Abdominal pain
5.2. Bloating after eating
5.3. Early satiety
5.4. Nausea
5.5. Vomiting
6. Capacity to give informed consent

Previous inclusion criteria:
1. Aged =18 years
2. Able to tolerate the oral diet
3. Confirmed diagnosis of sub-acute bowel obstruction due to underlying malignancy including those with colorectal or gynaecological cancers with a primary or secondary tumour in situ and those undergoing cancer treatment or supportive care
4. Patients diagnosed with advanced inoperable cancers of colorectal or gynaecological origin
5. Presenting in outpatient clinics or admitted from A&E with a minimum of 2 symptoms of the following subacute bowel obstruction:
5.1. Abdominal pain
5.2. Bloating after eating
5.3. Early satiety
5.4. Nausea
5.5. Vomiting
6. Capacity to give informed consent

Exclusion Criteria

1. No symptoms of bowel obstruction
2. Have not already been given the advice to follow the 4 stage bowel obstruction diet
3. Unable to read and communicate in the English language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Acceptability of a 4 stage diet to patients measured using the ease of use questionnaire at 4 weeks <br>2. Symptoms of sub-acute bowel obstruction (abdominal pain, feeling bloated, feeling full-up quickly, nausea, or vomiting) measured using the Memorial Symptom Assessment Scale questionnaire (MSAS) at baseline and 4 weeks. The MSAS has been adapted to include the key additional symptom of early satiety that can be experienced by patients with sub-acute bowel obstruction and will be graded on a scale of 0 (not at all) to 4 (very much).

Secondary Outcome Measures

Name	Time	Method
1. A&E attendances or hospital admissions due to bowel obstruction will be measured from hospital records between 3 months prior to the study and baseline, and between baseline and 4 weeks <br>2. Health-related Quality of Life measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (QLQ-C30) at baseline and 4 weeks<br>3. Weight measured in kilograms and as a percentage indicating percentage weight change from start to end of the trial at baseline and 4 weeks