Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 stage bowel obstruction diet | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of sub-acute bowel obstruction: abdominal pain, feeling bloated, feeling full-up quickly, nausea and / or vomiting | 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). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A&E attendances or hospital admissions after starting to use the 4 stage diet | 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. | 4 weeks |
Not provided
Inclusion Criteria:
Patients over 18 years of age
Able to tolerate oral diet
Confirmed diagnosis of SBO due to underlying malignancy to include:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lindsey Allan | Royal Surrey NHS Foundation Trust | Principal Investigator |
| Agnieszka Michael | Royal Surrey NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey NHS Foundation Trust | Guildford | Surrey | GU2 7XX | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Health related Quality of Life |
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). |
| 4 weeks |
| Weight | 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. | 4 weeks |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided