Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Diarrhea

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Antisecretory factor

Salovum egg powder high in antisecretory factor, 4 g/sachet. Four sachets, ie 16 g q 8 h for 6 days starting 6 days before 1st cycle of chemotherapy. SPC-flakes flat dose of 75 g/d divided in 2 - 4 doses started in parallel with Salovum to be continued during the first 8 weeks of chemotherapy.

Salovum placebo powder without antisecretory factor, 4 g/sachet. Four sachets, ie 16 g q 8 h for 6 days starting 6 days before 1st cycle of chemotherapy. SPC placebo flakes flat dose of 75 g/d divided in 2 - 4 doses started in parallel with Salovum placebo to be continued during the first 8 weeks of chemotherapy.

Foods for specific medical purposes or corresponding placebo

Salovum and SPC-flakes active or placebo

Peter Nygren, MD

One debilitating, and sometimes even life-threatening, toxicity from dihydropyrimidines, e g 5-FU and capecitabine, is gastrointestinal mucositis resulting in, eg severe diarrhoea necessitating in-hospital care including periods of support with iv fluids. The efficacy of current treatment for this adverse effect include iv fluids, loperamide and opioids po and octreotide sc is moderate and new treatment principles or, preferably, ways to prevent such toxicity, are urgently needed. Cholera induced diarrhoea, as well as other forms of diarrhoea-inducing agents, has been shown to elicit a stimulated, endogenous production of a protein, named "antisecretory factor", ASF. ASF acts by modulating secretion of water and ions but also counteracts inflammatory processes.

ASF is also produced by hens fed on a diet of fermented grains or a specific diet of sugars and amino acids, leading to an accumulation of the ASF protein in the egg yolk. Spray dried yolk in the form of a powder is commercialized as Salovum registered by the EU authorities as "Food for specific medical purposes". Another way to increase ASF and, thus, to achieve benefit, is to induce its production/ conversion by ingestion of oat flakes, specially processed (similar to malting) to contain the proper mix of sugars and amino acids. Such flakes are also commercially available (SPC-flakes) as "Food for specific medical purposes".

Salovum has been shown to rapidly, ie within hours to a few days, antagonize diarrhoeal diseases of various etiologies. It has also been used against high fluid passages and inflammation in Crohns disease, Colitis ulcerosa and carcinoids in adults. SPC-flakes have similar effects but need weeks of administration to emerge. Interestingly from an oncological perspective, provision of exogenous ASF and induction of endogenous ASF has been shown to reduce interstitial fluid pressure (IFP) in tumours, increase tumour uptake of cytotoxic drugs and improve survival in animal tumour models.

With this background the present study will investigate if administration of ASF in the form of Salovum combined with induction of endogenous ASF by intake of SPC-flakes might be beneficial in colorectal cancer (CRC) patients to prevent dihydropyrimidine based chemotherapy induced gastrointestinal mucositis and to reduce tumor interstitial fluid pressure .

The pyrimidine analogue 5-fluorouracil (5-FU) has a history in oncology for more than 50 years, and is still the backbone in chemotherapy regimens, in particular for gastrointestinal cancer although it is now often substituted with the oral prodrug capecitabine. Since colorectal cancer is the third most common cancer in Europe and the US a great number of patients will be exposed to 5-FU either as part of a curative intent, ie (neo)adjuvant, or with a palliative intention.

One debilitating, and sometimes even life-threatening, toxicity from dihydropyrimidines, e g 5-FU and capecitabine, is gastrointestinal mucositis resulting in, eg severe diarrhoea necessitating in-hospital care including periods of support with iv fluids. The efficacy of current treatment for this adverse effect include iv fluids, loperamide and opioids po and octreotide sc is moderate and new treatment principles or, preferably, ways to prevent such toxicity, are urgently needed. Mucositis is a common adverse effect also from a number of other cancer drugs as well as from radiotherapy.

Cholera induced diarrhoea, as well as other forms of diarrhoea-inducing agents, has been shown to elicit a stimulated, endogenous production of a protein, named "antisecretory factor", ASF. This protein has been chemically characterized in detail. ASF acts by modulating secretion of water and ions but also counteracts inflammatory processes. One of the biologically active peptides of the ASF protein is AF 16, a 16 amino acids long peptide which can easily be synthesized, is chemically very stable, and is therefore used for experimental purposes.

ASF is also produced by hens fed on a diet of fermented grains or a specific diet of sugars and amino acids, leading to an accumulation of the ASF protein in the egg yolk. Spray dried yolk in the form of a powder is commercialized as Salovum registered by the EU authorities as "Food for specific medical purposes", i e is not a drug from a regulatory perspective. Therefore, clinical studies with Salovum (or SPC-flakes, see below) do not need approval from the Medical Products Agency.

Salovum rapidly increase the plasma ASF-concentration. Another way to increase ASF and, thus, to achieve benefit, is to induce its production/conversion by ingestion of oat flakes, specially processed (similar to malting) to contain the proper mix of sugars and amino acids. Such flakes are also commercially available (SPC-flakes) as "Food for specific medical purposes" and has been recommended or considered for a number of secretory pathological conditions, e g for treatment of Mb Meniére.

Salovum has been shown to rapidly, ie within hours to a few days, antagonize diarrhoeal diseases of various etiologies. It has also been used against high fluid passages and inflammation in Crohns disease, Colitis ulcerosa and carcinoids in adults. SPC-flakes have similar effects but need weeks of administration to emerge. Importantly, to raise body ASF, by Salovum or SPC-flakes, for the above indications has not been associated with adverse effects.

Interestingly from an oncological perspective, provision of exogenous ASF and induction of endogenous ASF has been shown to reduce interstitial fluid pressure (IFP) in tumours, increase tumour uptake of cytotoxic drugs and improve survival in animal tumour models.

Thus, to raise body ASF by administration of ASF in the form of Salovum or its endogenous induction by SPC-flakes is seemingly a promising strategy worthwhile to investigate in cancer, both for treatment and counteraction of adverse effects, notably gastrointestinal mucositis, and for improvement of drug cancer treatment. While a clinical trial on administration of ASF as a strategy to improve cancer therapy, notably in glioblastoma, is in a pilot early phase, there is no study ongoing with the aim to counteract chemotherapy induced mucositis.

With this background the present study will investigate if administration of ASF in the form of Salovum combined with induction of endogenous AF by intake of SPC-flakes might be beneficial in colorectal cancer (CRC) patients to prevent dihydropyrimidine based chemotherapy induced gastrointestinal mucositis. Since the study team has also experience from measurements in patients of tumour IFP using 15O-labeled water PET, a pharmacodynamic pilot study for assessement of Salovum/SPC induced changes in tumour IFP will be included as an add on to the main study and open for 10 patients with liver metastatic disease.

Placebo study products similar to the active products

Role of Antisecretory Factor in Dihydropyrimidine Treatment of Colorectal Cancer

A Randomized Phase 2 and Pilot Pharmacodynamic Trial Investigating the Effect of Salovum™ and SPC-flakes on Dihydropyrimidine Induced Gastrointestinal Toxicity and Tumour Perfusion in Colorectal Cancer

Assessment of change in tumor interstitial fluid pressure by antisecretory factor

Chemotherapy induced toxicity to be counteracted by intervention

Patient reported chemotherapy induced toxicity to be counteracted by intervention

To reflect study products pharmacodynamics and patient compliance

Assessment of biomarker related to potential benefit

Assessment of benefit, if any, from ASF elevation on drug efficacy

Assessment of study product safety when combined with chemotherapy

Lantmännen AB

Sjöbergstiftelsen

Onkologiska klinikens forskningsfond

Swedish Cancer Society

Uppsala University Hospital

Professor in oncology, consultant in oncology

Substance Related Disorders

Rare Diseases

Syndrome

Neuroendocrine Tumors

Flushing

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Neuroendocrine Tumor

Carcinoid Syndrome

Neuroepithelioma

Pharmaceutical Solutions

Antineoplastic Agents

Lanreotide

Somatostatin

Hormones

Hormone Antagonists

Subjects received deep s.c. lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).

After completing the DB phase (or if they met criteria for early roll over \[ERO\]) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained \[whichever occurred first\]).

Subjects received deep s.c. placebo every 4 weeks (±3 days) for 16 weeks (DB phase).

After completing the DB phase (or if they met criteria for ERO) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained \[whichever occurred first\]).

deep s.c. injection, 120 mg, every 4 weeks (±3 days).

deep s.c. injection of placebo (0.9% saline solution) every 4 weeks (±3 days) for 16 weeks, then deep s.c. injection of lanreotide 120 mg, every 4 weeks (±3 days).

Placebo

Ipsen Medical Director

The purpose of this study was to determine whether monthly deep subcutaneous (s.c.) injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue medication to control symptoms in subjects with carcinoid syndrome.

This study consisted of a Screening period, conducted up to 4 months before randomisation, followed by three phases: a 16-week, double blind (DB), randomised, placebo-controlled phase; a 32-week initial open label (IOL) phase; and a long term open label extension (LTOLE) phase.

The DB phase evaluated lanreotide Autogel versus placebo in subjects with a history of carcinoid syndrome (flushing and/or diarrhoea). This was followed by a 32-week IOL phase in which all subjects received lanreotide Autogel 120 mg every 4 weeks. Subjects in countries where lanreotide Autogel had not been approved for the treatment of carcinoid syndrome, who were well-controlled at the end of the 32-week IOL phase and chose to continue to receive lanreotide Autogel, were given the option of participating in a LTOLE phase. The LTOLE phase of the study was planned to end at least 2 years after the last subject had completed his/her participation in the 32-week IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome had been obtained in the respective countries (whichever occurred first) or at any time the study was terminated by the Sponsor. The actual overall duration of the study was 6.5 years. During the LTOLE phase all subjects continued to be treated with lanreotide Autogel 120 mg every 4 weeks.

The study planned to enrol approximately 100 adult subjects worldwide. Screening continued until 115 subjects were enrolled in the study.

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

A Double Blind, Randomized Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.

Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).

Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +...+ In)/n.

For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +...+ In)/n.

For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Ipsen

Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo.

Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.

Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)

Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.

Placebo (DB Phase)

All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).

Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)

All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).

Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Lanreotide Autogel (Somatuline Depot) 120 mg

Total

Age, Continuous

Sex: Female, Male

Asian

Black/African American

White

Multi race

Race/Ethnicity, Customized

Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Medical Director, Oncology

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).

Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).

ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Percentage of Days With Subcutaneous Octreotide as Rescue Medication

Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.

Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.

Percentage of Days of Use of Other Rescue Medication

Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study

ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.

Changes From Baseline in "Global Health Status/Quality of Life (QoL)" Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)

Changes From Baseline in "Gastrointestinal (G.I). Symptoms" Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]

Changes From Baseline in QoL in "Endocrine Symptoms" Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)

Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])

Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.

DB Phase

IOL Phase

LTOLE Phase

Oculocerebral Syndrome With Hypopigmentation

Other Dietary Supplements

Acidophilus

Placebo is administered during chemotherapy.

Lactophilus supplementation is administered during chemotherapy.

Lactobacillus Rhamnosus supplementation

Placebo administration.

Heikki Joensuu, M.D.

Chemotherapy may cause diarrhoea, which may be associated with treatment delay and infections. The purpose of the study is to investigate whether oral supplementation with lactobacilli will alleviate chemotherapy related diarrhoea. Patients diagnosed with advanced colorectal cancer and who will receive chemotherapy will be randomly assigned to receive either lactobacilli or placebo during chemotherapy. The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The primary outcome measure is frequency of moderate/severe diarrhoea. The study will also address safety and tolerability of chemotherapy, response to chemotherapy, and serum growth factor levels.

This is a prospective, multicenter, randomized, cross-over, double-blind, placebo-controlled study. Patients diagnosed with advanced colorectal cancer with overt distant metastases and who will receive chemotherapy consisting of capecitabine, oxaliplatin and bevacizumab, given as 3-weekly cycles, will be randomly assigned to receive either lactobacilli (GefilusR) or placebo during the first 3 cycles of chemotherapy (for 9 weeks). Following this, the groups will be crossed over and those study participants who were allocated to lactobacilli will receive placebo for 9 weeks, and vice versa. Lactobacilli and placebo are administered twice daily. The total daily dose of lactobacilli is 20 billion CFU. The primary outcome measure is frequency of moderate/severe diarrhoea (grade 2-4). Adverse effects (including the frequency of diarrhoea, flatulence, bloating, constipation, and nausea) will be longitudinally monitored based on a patient diary and study visits. The study will also address safety and tolerability of chemotherapy, response to chemotherapy, progression-free survival, resectability of liver metastases, and serum growth factor levels. A total of 84 patients are planned to be entered.

Lactobacillus Rhamnosus in Prevention of Chemotherapy-related Diarrhoea

Randomized, Double Blind, Placebo Controlled, Cross-over Phase II Study on the Effects of Lactobacillus Rhamnosus GG Supplementation in Patients on 1st Line XELOXA Treatment for Metastatic Colorectal Cancer

Adverse effects detected in the study groups.

Helsinki University Central Hospital

University of Helsinki

professor

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Nutritional and Metabolic Diseases

Weight Loss

Constipation

Anorexia

Pain

Gastroesophageal Reflux

Body Weight

Nausea

Vomiting

Deglutition Disorders

Mucositis

Exocrine Pancreatic Insufficiency

Malabsorption Syndromes

Flatulence

Steatorrhea

Bile Acids and Salts

The study will be limited to NHS patients to reduce complications associated with the need for additional funding authorisations from private health care providers for algorithm-instigated investigations. It is not envisaged that participation in other studies running within the GI unit at The Royal Marsden Hospital will preclude entry into this study except in the event of those rare studies where the study is specifically measuring toxicity of treatment as the primary end point.

Jervoise Andreyev, MBBS, Ph.D

Linda Wedlake, RD MSc BSc

The aim of the study is to identify how often gastrointestinal problems interfere with quality of life as a result of treatment for cancer with chemotherapy. We also want to identify the causes for these symptoms and see if simple treatments used for other gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently, it can cause a whole range of physical side effects. Probably the most common side effects are those affecting the stomach and bowels. Vomiting used to be a major problem with chemotherapy but research discovered a whole series of new treatments so that severe vomiting from chemotherapy is rarely a problem today. However, patients can develop a whole series of other symptoms during chemotherapy, for example, bloating, wind, diarrhoea, needing to rush to the lavatory and opening the bowels very frequently. The causes for these symptoms have hardly been studied even though they sometimes affect people quite badly. In our specialist gastrointestinal clinic at the Royal Marsden Hospital, over the last 12 years, we have pioneered new methods for dealing with symptoms which affect the bowel after radiotherapy. We would like to extend these methods to people having chemotherapy. We have identified several easily treatable causes for these symptoms after radiotherapy, which previously were often ignored. We believe that some of these causes also occur in people having chemotherapy and if we knew how often they do occur we could focus on improving treatment for affected people. We plan to find out how often 40 stomach and bowel symptoms occur during chemotherapy. In people who are troubled by any or some of these symptoms we will arrange simple series tests which could sort out why these symptoms occur and we will record how they respond to treatment.

Chemotherapy (CT) remains an integral part of treatment for many types of cancer often in combination with surgery and/or radiotherapy. In the year March 2011 to April 2012, 1807 patients were referred to the Royal Marsden Hospital (RMH) Gastrointestinal Unit with a new gastro intestinal (GI) cancer of whom 709 were treated with chemotherapy alone or in combination with other long term outcome. GI symptoms are common in patients receiving chemotherapy. They may arise from the tumour, but may also result as a side effect of treatment. They include anorexia, borborygmi, bloating, constipation, diarrhoea, dysphagia, early satiety, frequency of defaecation, incontinence, mucus discharge, nausea, nocturnal defaecation, pain, reflux, regurgitation, steatorrhoea, tenesmus, urgency of defaecation, vomiting, weight loss and wind. Frequently, such symptoms have a significant impact on patients' quality of life. They may also interfere with the delivery of treatment prompting cessation of therapy or dose reduction resulting in sub optimal dosage with a potential impact on morbidity and mortality. Whilst clinicians have long focused on the management of vomiting and pain in cancer patients, less attention has been paid to the incidence, severity or optimal management of other GI symptoms. If the cause of these symptoms can be identified, then appropriate investigations and treatments can be prescribed. The GI Unit has successfully investigated and treated patients with symptoms emerging after radiotherapy. This experience has enabled the team to develop an algorithm for facilitating the investigation and treatment of cancer therapy induced symptoms. The algorithm has recently been shown to be effective in the management of patients with radiation induced bowel injury . In particular, it enables the rapid identification of required investigations and improves the management of symptoms that might otherwise be mislabeled as inevitable consequences of treatment. Five easily treatable causes for GI symptoms have so far been identified:

* Small bowel bacterial overgrowth
* Carbohydrate malabsorption
* Bile acid malabsorption
* Gastric bile reflux
* Pancreatic insufficiency

It is likely that additional causes such as viral infections (eg cytomegalovirus) are more frequent in patients undergoing chemotherapy than currently appreciated.

Blood and Stool Samples will be collected for translational analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Role of Antisecretory Factor in Dihydropyrimidine Treatment of Colorectal Cancer	NCT05339230	Dihydropyrimidi...	Salovum and SPC...	18 Years -	Uppsala University Hospital
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome	NCT00774930	Carcinoid Syndr...	Lanreotide Placebo	18 Years -	Ipsen
Role of Antisecretory Factor in Dihydropyrimidine Treatment of Colorectal Cancer	NCT05339230	Dihydropyrimidi...	Salovum and SPC...	18 Years -	Uppsala University Hospital
Lactobacillus Rhamnosus in Prevention of Chemotherapy-related Diarrhoea	NCT00197873	Colorectal Canc...	Lactobacillus R... Placebo adminis...	18 Years -	University of Helsinki
The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms"	NCT02121626	Cancer		18 Years - 90 Years	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for diarrhoea

Every month we try and update this database with for diarrhoea cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for diarrhoea

Every month we try and update this database with for diarrhoea cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for diarrhoea cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.