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

July 4, 2017 updated by: LUCIA VASSALLI, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients affected by invasive breast cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Patients affected by breast cancer and potentially treated with taxane chemotherapy
Group 2
Patients affected by breast cancer and not potentially treated without taxane chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment
Time Frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
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)
From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of dysgeusia
Time Frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- 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
From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of weight alterations
Time Frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
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))
From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of eating habits changes
Time Frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Food frequency questionnaire (FFQ), chemotherapy-induced taste alteration scale questionnaire (CiTAS)
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
Time Frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
functional assessment of cancer therapy questionnaire (FACT_B)
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
Time Frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
beck depression inventory (BDI) and HADS test
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
Time Frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI)
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
Time Frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
state and trait anxiety inventory (STAI-Y) will be administered to patients
from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Lucia Vassalli, MD, ASST Spedali Civili Di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 6, 2014

Primary Completion (ANTICIPATED)

May 6, 2018

Study Completion (ANTICIPATED)

May 6, 2018

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (ACTUAL)

July 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP2488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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