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

NCT03210441 | Unknown

• 1 other identifier: NP2488
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Dysgeusia; Eating Behavior; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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)

  From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy

Secondary Outcomes (7)

• Evaluation of dysgeusia

  From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy

• Evaluation of weight alterations

  From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy

• Evaluation of eating habits changes

  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

  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

  from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by invasive breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Breast Neoplasms; Dysgeusia; Feeding Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Lucia Vassalli, MD

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Vassalli, MD

CONTACT

lucia.vassalli@libero.it

Filippo Rodella

CONTACT

0303996536; oncotrialbrescia@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: July 7, 2017
• Study Start: May 6, 2014
• Primary Completion: May 6, 2018
• Study Completion: May 6, 2018
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)