Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet

Not Applicable

Completed

• Conditions: Metastatic Ovary Cancer; Peritoneal Carcinomatosis; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Adenocarcinoma; Colorectal Cancer Metastatic; Ovarian Neoplasm; Metastatic Colorectal Cancer; Colorectal Cancer; Ovarian Cancer
• Interventions: Other: Dietary intervention

• Registration Number: NCT04898842
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

Bowel obstruction is a common complication in patients with ovarian, peritoneal and bowel cancer due to a mass or spread of disease, causing narrowing to the gut, as these cancers can grow on the bowel surface. Certain foods may lead to symptoms such as pain, bloating, feeling full, feeling sick, vomiting and difficulty passing a bowel motion.

There is limited evidence to establish the best diet to follow when someone is diagnosed with the risk of bowel obstruction and is experiencing symptoms after eating and drinking.

The Dietitians at the Royal Surrey have developed a 4 stage bowel obstruction diet which they have been using with patients for 3 years. The 4 stages are clear fluids, all thin liquids, low fibre soft smooth diet, low fibre soft sloppy diet. Depending on the severity of symptoms and the risk of a blockage, patients are asked to follow a certain stage of the diet. They are advised to move up and down the stages as symptoms improve or get worse.

This feasibility study aims to investigate if the diet can be used and is effective in clinical practice. The objectives are to see if this diet is easy to follow, can reduce symptoms of bowel obstruction, can improve quality of life, and reduce admissions to hospital because of bowel blockages.

Patients at risk of bowel obstruction from colorectal or ovarian cancer are eligible to participate. They will remain in the study for a period of 4 weeks, during which time they will be asked to complete a diet diary and 3 questionnaires.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-06
• Study Start: 2021-03-02
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-24
• Primary Completion: 2022-10-05
• Study Completion: 2022-11-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

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

Inclusion Criteria

• Patients over 18 years of age

• Able to tolerate oral diet

• Confirmed diagnosis of SBO due to underlying malignancy to include:

  1. Patients with colorectal or gynaecological cancers with primary or secondary tumour in situ, undergoing cancer treatment or supportive care.
  2. Patients diagnosed with advanced inoperable cancers of colorectal or gynaecological origin

• Presenting in outpatient clinics or admitted from A&E with a minimum of 2 symptoms of SBO including: abdominal pain, bloating after eating, early satiety, nausea, vomiting

• Capacity to give informed consent

Exclusion Criteria

• Patients under 18 years of age
• No symptoms of bowel obstruction
• Have not already been given advice to follow the 4 stage bowel obstruction diet
• Unable to tolerate oral diet i.e. enterally or parenterally fed
• Unable to provide capacity to give informed consent
• Unable to read and communicate in the English language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4 stage bowel obstruction diet	Dietary intervention	All eligible participants will be assessed by a specialist dietitian and a diet history and symptoms will be recorded. Depending on the degree of sub-acute bowel obstruction, symptoms and type of diet being followed, patients will be given detailed instructions on which stage of the 4 stage diet to use. They will be followed up by telephone or face to face weekly for a 4 week period and shown how to alter their diet by moving up and down the stage of the diet if symptoms resolve or worsen. This is current standard of care. Additional assessments will be carried out at the start and end of the study when participants will complete the Memorial Symptom Assessment Scale (MSAS) and EORTC QLQ-30 quality of life questionnaire. They will be asked to complete a daily diet diary, and an 'ease of use' questionnaire at the end of the 4 week period.

Primary Outcome Measures

Name	Time	Method
Symptoms of sub-acute bowel obstruction: abdominal pain, feeling bloated, feeling full-up quickly, nausea and / or vomiting	4 weeks	Measured by completion of the Memorial Symptom Assessment Scale questionnaire (MSAS): a well-validated questionnaire, which asks about the frequency, severity and psychological effect of 32 symptoms. For the purpose of this study, the MSAS has been adapted to include the key additional symptom of early satiety (feeling full up quickly) that can be experienced by patients with sub-acute bowel obstruction. It is graded on a scale of 0 (not at all) - 4 (very much).

Secondary Outcome Measures

Name	Time	Method
A&E attendances or hospital admissions after starting to use the 4 stage diet	4 weeks	No of hospital admissions and A\&E attendances due to bowel obstruction in the 3 months prior to consent will be recorded. This will be compared with the number of admissions during the 4 weeks patients are on the trial.
Weight	4 weeks	Measured in kilograms and as a percentage indicating percentage weight change from start to end of the trial. Participants will be weighed on consent and after 4 weeks.
Health related Quality of Life	4 weeks	Measured by using the EORTC Quality of Life QLQ-C30 questionnaire will be collected at baseline on entry to the study and after 4 weeks on completion of the study. QLQ-C30 developed by EORTC is designed to measure cancer patients' physical, psychological and social functions. It is scored on a scale from 0 (not at all) - 4 (very much).

Trial Locations

Locations (1)

Royal Surrey NHS Foundation Trust; 🇬🇧 Guildford, Surrey, United Kingdom