Clinical trial NCT03210441: Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment in Patients Affected by Breast Cancer
Official title: Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment: a Prospective Cohort Study on Patients Affected by Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Dysgeusia
Eating Behavior
Quality of Life
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by invasive breast cancer

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pre- and post-menopause women with histologic diagnosis of invasive breast cancer surgically treated (all pT and all pN)
* Patients must provide written informed consent to be enrolled in the study

Exclusion Criteria:

* Locally extended or metastatic (M1) disease;
* Previous surgical or radio therapeutic treatment (up to one year before the selection) in oral or nasal region;
* Other serious medical conditions that can limit patient capability to participate in this study.

Primary outcomes:
measure: To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment
timeFrame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Secondary outcomes:
measure: Evaluation of dysgeusia
timeFrame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
measure: Evaluation of weight alterations
timeFrame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
measure: Evaluation of eating habits changes
timeFrame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
measure: Evaluation of the impact of eating habits changes and dysgeusia on quality of life
timeFrame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
measure: Evaluation of the impact of eating habits changes and dysgeusia on depression
timeFrame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
measure: Evaluation of the impact of eating habits changes and dysgeusia on insomnia
timeFrame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
measure: Evaluation of the impact of eating habits changes and dysgeusia on anxiety, depression
timeFrame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Lucia Vassalli, MD
role: PRINCIPAL_INVESTIGATOR
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