Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Weight Loss

Esophageal Neoplasms

Body Weight

Weight Gain

Body Weight Changes

Esophageal Cancer

All Drugs and Chemicals

Psychotropic Drugs

Antineoplastic Agents

Gastrointestinal Agents

Central Nervous System Depressants

Hormones

Somatostatin

Antidepressive Agents

Octreotide

Mirtazapine

This cohort will be the group who are undergoing routine clinical treatment with a long-acting somatostatin analogue to minimise abnormal gut hormone signalling, and thus reduce early satiety.

This cohort will be the group who are undergoing routine clinical treatment with a tetracyclic antidepressant to stimulate appetite.

Patients undergo clinical treatment as indicated, they are studied before and after.

Clinical treatment

The investigators aim to ascertain how food reward signals and eating behaviour relates to the gut-brain pathway in weight-losing patients after curative surgery for oesophageal cancer, and how this pathway responds to clinical treatment for this unintentional weight loss. The primary outcomes are the blood oxygen level dependent (BOLD) signal on functional MRI (fMRI), and the breakpoint during the progressive ratio task (PRT - a measure of eating behaviour), how these differ in response to multiple clinical treatment options, as well as how they relate to weight gain while on treatment.

The incidence of cancer of the oesophagus (food pipe) is increasing. Improvements in treatment strategies have resulted in more people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with oesophageal cancer, but while surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Poor appetite, weight loss and nutritional impairment are common problems among patients who attain long-term cancer remission and cure after surgery.

A new clinic has been established to treat patients who are in remission but who have lost more than 10% of their body weight secondary to the effects of the surgery and struggling to regain weight. These patients will be treated as per standard of care with medications to aid weight gain.

The investigators are interested to conduct research into how the reward value of food changes during the clinical treatment pathway. The hypothesis is that there will be an increased reward response to food after medication use, the magnitude of which will correlate with weight gain. To assess this, patients who are already part of this clinic will be approached to have fMRI that can demonstrate changes in brain reward centres as well as a Progressive Ratio Task, which is a direct measure of appetitive behaviour. Changes in brain reward centre responses and appetitive behaviour will be correlated with changes in weight after pharmacotherapy. This may further inform future clinical protocols to provide improved precision medicine.

Resection of the Esophagus and Subsequent Weight Loss

The Effect of Clinical Treatment for Unintentional Weight Loss on Food Reward and Appetitive Behaviour in Patients Who Have Lost >10% of Their Body Weight After Undergoing Curative Surgery for Oesophageal Cancer

Relationship of food reward changes to weight gain

Relationship of eating behaviour changes to weight gain

University College Dublin

St. James's Hospital, Ireland

Imperial College London

Professor of experimental pathology, Reader in investigative science

Skin and Connective Tissue Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Dysgeusia

Breast Diseases

Skin Diseases

Taste Disorders

Sensation Disorders

Neurologic Manifestations

Quality of Life

Taxane

Patients affected by breast cancer and potentially treated with taxane chemotherapy

Patients affected by breast cancer and not potentially treated without taxane chemotherapy

Lucia Vassalli, MD

Filippo Rodella

In post-menopause women affected by breast cancer and treated with chemotherapy, overweight and obesity are considered both a risk factors as well as a negative prognostic factors since they increase the risk of early relapse and death. Furthermore, a decrease in weight may also occur during chemotherapy and is associated to a reduced quality of life and survival. Also, the majority of patients under chemotherapy refer dysgeusia, an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. Our aim is to evaluate eating habits changes in patients affected by breast cancer and under chemotherapy treatment and to better understand how this alterations influence the quality of life, anxiety, depression and insomnia of patients as well as overall survival.

INTRODUCTION

Overweight and obesity represent a risk factor for hormone dependent cancers such as breast, endometrium, ovarian, uterine and gastrointestinal cancer.

In particular, overweight and obesity are risk factors for breast cancer in post-menopause women since they are associated to higher level of circulating estrogens, insulin, insulin-like growth factor levels, leptin, adiponectin, growth factors (such as hepatocyte growth factor) and inflammatory cytokines (TNFα and Interleukin-6 (IL-6)). Moreover, they reduce sex hormone binding globulin (SHBG) plasma levels. Overweight and obesity are also negative prognostic factors for breast cancer in post-menopause women since they increase the risk of early relapse and death. An increased weight (2.5-6.2 Kg) is commonly reported during chemotherapy treatment in post-menopause women. This is due to increased appetite, hyperphagia and hydric retention associated with reduced metabolism and physic activities. However, the weight gain during therapy is still not recognised as a negative prognostic factor.

Furthermore, a decrease in weight may also occur during chemotherapy. This is mainly due to lower appetite and early satiety, dysgeusia, nausea and vomiting or intolerance to certain foods. Decreasing weight can determine less efficacy and tolerance in therapy, more complications/infections, more and longer hospitalisations and, as a consequence, a reduced quality of life and survival.

Dysgeusia is an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. More than 75% of patients under chemotherapy refer dysgeusia; this is related to drugs (such as folic acid competitors, cyclophosphamide cisplatin and taxanes) and can last for weeks. ln particular, taxanes determine a peripheral nerves degeneration. The results are a metallic taste and an alteration in salted perception. In addition, they determine a dose-dependent chemotherapy-induced peripheral neuropathy (CIPN) with painful paraesthesia, total areflexia and muscular extremities weakness. Dysgeusia is an underestimated problem. Instrumental examinations and laboratory tests can be useful but they cannot replace a detailed medical history and a close physical examination associated with international validate questionnaires.

At the moment, no agreement was found on chemotherapy-induced dysgeusia prevention and therapy. Patients resolve this problems with cold food, candies before meals and sugary drinks and these behaviours lead to increasing in weight.

STUDY DESIGN

This is a prospective cohort study for the evaluation of eating habits changes and dysgeusia in patients with breast cancer during chemotherapy treatment. It will explore also the potential relations with anxiety, depression, insomnia and quality of life. These evaluations will be actuated using internationally validate questionnaires.

METHODS

This study is based on the collection of data with international validate questionnaires:

* Food frequency questionnaire (FFQ) and photography atlas
* Chemotherapy-induced taste alteration scale (CiTAS): evaluation of changes in taste.
* Functional assessment of cancer therapy (FACT_B): evaluation of quality of life for physical health, social and familiar health, emotional health, functional health and health in relation with the pathology.
* Beck depression inventory (BDI) and HADS: evaluation of depression presence and its intensity.
* Pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI): evaluation of sleep quality.
* State and trait anxiety inventory (STAI-Y): evaluation of anxiety presence and its intensity.

STATISTICAL CONSIDERATIONS

Based on the proportion of the women in overweight before chemotherapy is 30% and the proportion of the women in overweight after chemotherapy is 50% (with a 5% α error and an 80% strength), the established number of patients to include in the study is 186. In prevision of a 10% loss of patients in follow-up, 204 patients will be included in the study.

Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment in Patients Affected by Breast Cancer

Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment: a Prospective Cohort Study on Patients Affected by Breast Cancer

Appearence of dysgeusia, asthenia, diarrhoea, decreased or increased appetite, mucositis, nausea, stypsis, vomiting and meteorism will be evaluated throught Food frequency questionaire (FFQ) compared to baseline (nefore chemotherapy)

Presence of changes in food taste (sweet, salt, bitter) and food smell compared to baseline in patients treated with taxanes throught the evaluation of a food questionnaire

Evaluation of the correlation between eating habits changes and dysgeusia with changes in weight through weight/height measurement and BMI calculation to evaluate the influence of eating habits changes and changes in weight on outcome in patients (relapse free interval (RFI) and overall survival (OS))

Food frequency questionnaire (FFQ), chemotherapy-induced taste alteration scale questionnaire (CiTAS)

functional assessment of cancer therapy questionnaire (FACT_B)

beck depression inventory (BDI) and HADS test

pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI)

state and trait anxiety inventory (STAI-Y) will be administered to patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Resection of the Esophagus and Subsequent Weight Loss	NCT03377660	Esophageal Canc... Weight Gain Eating Behavior Food Reward	Clinical treatm...	18 Years -	Imperial College London
Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment in Patients Affected by Breast Cancer	NCT03210441	Breast Cancer Dysgeusia Eating Behavior Quality of Life		18 Years -	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Spots Global Cancer Trial Database for eating behavior