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

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ClinicalTrials.gov Identifier: NCT03210441
Recruitment Status : Unknown
Verified July 2017 by LUCIA VASSALLI, Azienda Ospedaliera Spedali Civili di Brescia.
Recruitment status was:  Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
LUCIA VASSALLI, Azienda Ospedaliera Spedali Civili di Brescia

Tracking Information
First Submitted Date June 15, 2017
First Posted Date July 7, 2017
Last Update Posted Date July 7, 2017
Actual Study Start Date May 6, 2014
Estimated Primary Completion Date May 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2017)
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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 4, 2017)
  • 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
  • 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))
  • 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)
  • 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)
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients affected by invasive breast cancer
Condition
  • Breast Cancer
  • Dysgeusia
  • Eating Behavior
  • Quality of Life
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 4, 2017)
204
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 6, 2018
Estimated Primary Completion Date May 6, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03210441
Other Study ID Numbers NP2488
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party LUCIA VASSALLI, Azienda Ospedaliera Spedali Civili di Brescia
Study Sponsor Azienda Ospedaliera Spedali Civili di Brescia
Collaborators Not Provided
Investigators
Principal Investigator: Lucia Vassalli, MD ASST Spedali Civili di Brescia
PRS Account Azienda Ospedaliera Spedali Civili di Brescia
Verification Date July 2017