Clinical trial NCT04898842: Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet
Official title: BOUNCED: Managing Oral Diet Following a Diagnosis of Sub-acute Bowel Obstruction: a Feasibility Study Exploring the Efficacy of a 4 Stage Bowel Obstruction Cancer Diet and Quality of Life in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Adenocarcinoma
Colorectal Cancer Metastatic
Ovarian Cancer
Ovarian Neoplasm
Metastatic Colorectal Cancer
Metastatic Ovary Cancer
Peritoneal Carcinomatosis
Bowel Obstruction
Keywords: diet
dietary intervention
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptoms of sub-acute bowel obstruction: abdominal pain, feeling bloated, feeling full-up quickly, nausea and / or vomiting
timeFrame: 4 weeks
Secondary outcomes:
measure: A&E attendances or hospital admissions after starting to use the 4 stage diet
timeFrame: 4 weeks
measure: Health related Quality of Life
timeFrame: 4 weeks
measure: Weight
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Surrey NHS Foundation Trust
name: Lindsey Allan
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Surrey NHS Foundation Trust
name: Agnieszka Michael
role: PRINCIPAL_INVESTIGATOR
References: