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NCT Number: NCT04898842

Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet

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.

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Key information

Conditions

Colorectal Cancer Abdominal Neoplasms Adnexal Diseases Bowel Obstruction Colonic Diseases Colorectal Adenocarcinoma Colorectal Cancer Metastatic Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Intestinal Obstruction Metastatic Colorectal Cancer Metastatic Ovary Cancer Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasm Ovarian Neoplasms Peritoneal Carcinomatosis Peritoneal Diseases Peritoneal Neoplasms Rectal Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Surrey NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age
  • Able to tolerate oral diet
  • Confirmed diagnosis of SBO due to underlying malignancy to include:
  • Patients with colorectal or gynaecological cancers with primary or secondary tumour in situ, undergoing cancer treatment or supportive care.
  • 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

Treatment and study plan

Dietary Intervention

Other

To determine whether a 4 stage bowel obstruction diet as a means of managing oral intake in patients symptomatic with malignant sub-acute bowel obstruction (SBO) is deliverable and effective in clinical practice.

Primary outcomes

  1. Symptoms of sub-acute bowel obstruction: abdominal pain, feeling bloated, feeling full-up quickly, nausea and / or vomiting

    Time frame: 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 outcomes

  1. A&E attendances or hospital admissions after starting to use the 4 stage diet

    Time frame: 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.

  2. Health related Quality of Life

    Time frame: 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).

  3. Weight

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: BOUNCED

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 24, 2021
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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