Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Abdominal Neoplasms

Peritoneal Neoplasms

Intestinal Obstruction

Peritoneal Diseases

Ovarian Diseases

Endocrine Gland Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

All Drugs and Chemicals

Vitamins

Trace Elements

All patients will be assessed and given an individual plan for Elemental Diet (ED) introduction. The actual amount of ED prescribed will depend on the tolerance and palatability and not nutritional status. The recommendation of a minimum of 2 cartons of ED will be drunk orally by patients, along with other clear fluids only. Following introduction of ED, patients will be discharged from hospital (if applicable) and followed up for 2 weeks. They will have a telephone follow-up assessment once a week for 2 weeks. All other assessments will follow the standard of care. During the follow-up patients will be assessed using the Memorial Symptom Assessment Scale (MSAS) and will be asked to complete a nutritional diary every day and a quality of life questionnaire at several time points.

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.

Elemental 028 Extra Liquid

Eleanor Smith

Agnieszka Michael, MBBS PhD

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

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.

EDMONd - Elemental Diet in Bowel Obstruction

A Feasibility Study of Elemental Diet as an Alternative to Parenteral Nutrition for Patients With Inoperable Malignant Bowel Obstruction

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).

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).

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).

Measured by reviewing hospital case notes

Measured by number of cartons taken by patient in 24 hours

University of Surrey

Target Ovarian Cancer

Royal Surrey County Hospital NHS Foundation Trust

Consultant in Medical Oncology

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Fallopian Tube Neoplasms

Fallopian Tube Diseases

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Lenograstim

Tubulin Modulators

Antimitotic Agents

All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.

Filgrastim

Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly paclitaxel/carboplatin regimen in gynaecological cancers.

Purpose: This multicenter phase II trial is studying the side effects of weekly paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or cervical carcinoma. Data obtained in this trial will be compared with historical data as published earlier.

The trial will include 3 cohorts of 36 patients:

* Subjects with ovarian, fallopian tube or peritoneal carcinoma
* Subjects with endometrial cancer
* Subjects with cervical carcinoma

Treatment:

Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2 years and then if clinically indicated. Subjects who develop disease progression will discontinue therapy. Subjects who have no evidence of disease progression after completion of study therapy will be followed until disease progression, withdrawal of informed consent, or death.

Primary objective:

- To evaluate the occurrence of grade 4 neutropenia during weekly paclitaxel/carboplatin with prophylactic G-CSF

Secondary objectives:

* To evaluate per cohort the occurrence of grade 4 neutropenia
* To evaluate other toxicities
* To evaluate the dose reductions or dose delays in the chemotherapy
* To determine the progression free survival according to RECIST v1.1
* To evaluate the response rate and overall survival

Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers

Belgian Gynaecological Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EDMONd - Elemental Diet in Bowel Obstruction	NCT03150992	Ovarian Cancer Ovarian Neoplas... Ovarian Disease Peritoneal Neop... Peritoneal Dise... Metastatic Ovar... Primary Periton... Abdominal Neopl... Bowel Obstructi...	Elemental 028 E...	18 Years - 90 Years	Royal Surrey County Hospital NHS Foundation Trust
Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers	NCT01523678	Ovarian Cancer Endometrial Can... Uterine Cervica...	Filgrastim Paclitaxel Carboplatin	18 Years -	Belgian Gynaecological Oncology Group
EDMONd - Elemental Diet in Bowel Obstruction	NCT03150992	Ovarian Cancer Ovarian Neoplas... Ovarian Disease Peritoneal Neop... Peritoneal Dise... Metastatic Ovar... Primary Periton... Abdominal Neopl... Bowel Obstructi...	Elemental 028 E...	18 Years - 90 Years	Royal Surrey County Hospital NHS Foundation Trust

Spots Global Cancer Trial Database for peritoneal diseases