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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 : 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

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.

Condition or disease
Breast Cancer Dysgeusia Eating Behavior Quality of Life

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment: a Prospective Cohort Study on Patients Affected by Breast Cancer
Actual Study Start Date : May 6, 2014
Estimated Primary Completion Date : May 6, 2018
Estimated Study Completion Date : May 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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))

  3. 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)

  4. 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)

  5. 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

  6. 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)

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by invasive breast cancer
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210441


Contacts
Contact: Lucia Vassalli, MD lucia.vassalli@libero.it
Contact: Filippo Rodella 0303996536 oncotrialbrescia@gmail.com

Locations
Italy
Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Lucia Vassalli, MD       lucia.vassalli@libero.it   
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
Principal Investigator: Lucia Vassalli, MD ASST Spedali Civili di Brescia

Publications of Results:
Other Publications:

Responsible Party: LUCIA VASSALLI, MD, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03210441     History of Changes
Other Study ID Numbers: NP2488
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dysgeusia
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms