Abdominal Neoplasm, Bowel Obstruction, Metastatic Ovarian Cancer, Ovarian Cancer, Ovarian Disease, Ovarian Neoplasms, Peritoneal Diseases, Peritoneal Neoplasms, Primary Peritoneal Carcinoma
Conditions
Keywords
Feasibility, Elemental Diet, Quality of life, Palliative, Nutrition, Ovarian, Peritoneal, Advanced, Metastatic, Bowel obstruction, Inoperable
Brief summary
A feasibility study to provide 'proof of concept' of Elemental Diet (ED) as an acceptable/ useful feeding option for patient with inoperable malignant bowel obstruction and to examine the impact of ED on quality of life
Detailed description
The aim of this study is to determine whether Elemental Diet (a type of drink that contains an elemental protein source known as amino acids) can be tolerated by patients with inoperable bowel blockage who can no longer eat and are only able to swallow small amount of fluid. The objective is to find out whether elemental diet (ED) can be used as an acceptable nutrition and whether it improves the quality of life. Bowel blockage is a common complication in patients with ovarian cancer. Unfortunately when the cancer is advanced, this blockage can occur in many parts of the bowel therefore surgery is not possible. Every year in the UK some publications report the rate as high as 50% . One way to feed patients with bowel blockage is through the veins; this is known as parenteral nutrition (PN) however PN is rarely used in United Kingdom. Patients with malignant bowel blockage are often able to swallow small amounts of liquid but if they have no PN they are only able to survive for 2-3 weeks and the psychological as well as physical impact on patients and the family are very distressing. ED is a type of a drink which contains an elemental protein source known as amino acids. ED drinks are almost totally absorbed in the upper part of the bowel and therefore could be absorbed even in patients who have bowel blockage which usually develops lower down in the gut. If this study is successful and proves that ED can be tolerated and provide nutrition to patients with inoperable bowel blockage it will be a big step towards improving the quality of life at the final stage of cancer.
Interventions
DIETARY_SUPPLEMENTElemental 028 Extra Liquid
A nutritionally complete, liquid elemental diet consisting of a mixture of essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements and flavourings with sugars & sweeteners.
Sponsors
University of Surrey
Target Ovarian Cancer
Royal Surrey County Hospital NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Confirmed inoperable bowel obstruction due to disseminated malignancy * Ability to tolerate 500ml of liquid * Capacity to give informed consent
Exclusion criteria
* Bowel obstruction that can be managed with surgical intervention * Complete bowel obstruction and inability to tolerate small amount of liquid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taste acceptability of ED | Two weeks | Taste of at least one flavor of ED graded as 2 out of 5 by patient on nutritional diary taste acceptability scale (1=I really like the taste, 2=I like the taste, 3=The taste is acceptable, 4=I do not like the taste but can drink it, 5=I do not like the taste and cannot drink it). |
| Change in incidence of vomiting | Two weeks | No deterioration in incidence of vomiting as measured on MSAS scale. Grading 1 (occurring rarely) or 2 (occurring occasionally) is acceptable. Deterioration considered as change to 3 (occurring frequently) or 4 (occurring almost constantly). |
| Change in incidence of pain | Two weeks | No deterioration in incidence of abdominal pain as measured on MSAS scale. Grading 1 (occurring rarely) or 2 (occurring occasionally) is acceptable. Deterioration considered as change to 3 (occurring frequently) or 4 (occurring almost constantly). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional intake | Two weeks | Measured by number of cartons taken by patient in 24 hours |
| Health related quality of life | Two weeks | Measured on EORTC-QLQ-C30 |
| The number of patients who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy | Two weeks | Measured by reviewing hospital case notes |
| Number of patients alive at the end of the study | Up to two years | Measured by reviewing hospital case notes |
Countries
United Kingdom
Contacts
Primary ContactEleanor Smith
Outcome results
None listed