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Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer

NCT ID: NCT03759548

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-12-31

Brief Summary

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Cancer patients undergo many different modalities of treatments. Pharmacological treatment should be well understood. The nutritional status is not taken into account when calculating drug's doses and this may have an impact in toxicity and quality of life. The present study proposes to evaluate the relationship between the calculation of pharmacological treatment's doses, the toxicity and the impact on quality of life among colorectal and breast cancer's patients.

Detailed Description

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Cancer patients undergo various treatment modalities depending on tumor type, location, disease staging, and overall clinical conditions. Pharmacological treatments and surgeries are fundamental therapeutic strategies in many cases and are part of the daily routine of integrated cancer treatment services. The calculation of pharmacological doses often takes into account the patient's body surface area (BSA) or only weight, without however assessing their nutritional status as such. The surgical procedure, on the other hand, may expose the patient to an inflammatory response secondary to the operative trauma that requires immediate reaction of the diseased organism for an adequate recovery. In this sense, the objective of the present study is to evaluate the relationship between the calculated medication's doses and the nutritional status of patients submitted topharmacological treatment with neoadjuvant or adjuvant intention: patients candidates for surgery. Different instruments will be used for nutritional assessment, as well as a questionnaire on quality of life, a specific criterion for evaluation of toxicities, laboratory tests and imaging. Patients will be observed for 1 year and the data collected will allow the analysis of possible side effects and the impact on quality of life.

Conditions

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Nutritional Status Colorectal Cancer Breast Cancer

Keywords

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Nutritional Status Colorectal Cancer Breast Cancer Pharmacological Treatment Toxicity Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer

Breast Cancer's patients undergoing pharmacological treatments prior or after surgery.

Assessment of nutritional status

Intervention Type OTHER

Observational study. Assessment of nutritional status.

Colorectal Cancer

Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery.

Assessment of nutritional status

Intervention Type OTHER

Observational study. Assessment of nutritional status.

Interventions

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Assessment of nutritional status

Observational study. Assessment of nutritional status.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pathological diagnosis of Colorectal Cancer or Breast Cancer
* Must have Performance Status to undergo surgery and pharmacological treatment (Adjuvant or Neoadjuvant treatment)

Exclusion Criteria

* Non-operable patients
* Pacientes with poor Performance Status Eastern Cooperative Oncology Group (PS ECOG) \>2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mater Dei Hospital, Brazil

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Maria Isabel Toulson Davisson Correia

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rede Mater Dei de Saúde - Hospital Integrado do Câncer

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Bernardo Coelho, MD

Role: primary

Other Identifiers

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CAAE: 91570318.5.0000.5149

Identifier Type: -

Identifier Source: org_study_id