An observational study in Breast Cancer, Dysgeusia and Eating Behavior, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-07.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Observational
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:
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 204 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
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Patients affected by invasive breast cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients affected by breast cancer and potentially treated with taxane chemotherapy
Patients affected by breast cancer and not potentially treated without taxane chemotherapy
To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment
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)
Time frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of dysgeusia
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
Time frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of weight alterations
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))
Time frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of eating habits changes
Food frequency questionnaire (FFQ), chemotherapy-induced taste alteration scale questionnaire (CiTAS)
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on quality of life
functional assessment of cancer therapy questionnaire (FACT_B)
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on depression
beck depression inventory (BDI) and HADS test
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on insomnia
pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI)
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on anxiety, depression
state and trait anxiety inventory (STAI-Y) will be administered to patients
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Plan to share: No
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia