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Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet (BOUNCED)

R

Royal Surrey County Hospital NHS Foundation Trust

Status

Completed

Conditions

Colorectal Carcinoma
Colorectal Adenocarcinoma
Metastatic Colorectal Cancer
Ovarian Neoplasm
Metastatic Ovary Cancer
Bowel Obstruction
Colorectal Neoplasms
Ovarian Cancer
Colorectal Cancer Metastatic
Peritoneal Carcinomatosis
Colorectal Cancer

Treatments

Other: Dietary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04898842
20DCSN272626

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

4 stage bowel obstruction diet
Experimental group
Description:
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.
Treatment:
Other: Dietary intervention

Trial contacts and locations

1

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Central trial contact

Kate Penhaligon; Lindsey Allan

Data sourced from clinicaltrials.gov

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