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

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ClinicalTrials.gov Identifier: NCT03759548
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
Mater Dei Hospital, Brazil
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

Brief Summary:
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.

Condition or disease Intervention/treatment
Nutritional Status Colorectal Cancer Breast Cancer Other: Assessment of nutritional status

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Breast Cancer
Breast Cancer's patients undergoing pharmacological treatments prior or after surgery.
Other: Assessment of nutritional status
Observational study. Assessment of nutritional status.

Colorectal Cancer
Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery.
Other: Assessment of nutritional status
Observational study. Assessment of nutritional status.




Primary Outcome Measures :
  1. Impact in Quality of Life during pharmacological treatments [ Time Frame: 1 year ]
    Impact in Quality of Life as assessed by European Organization for Research Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)


Secondary Outcome Measures :
  1. Pharmacological treatment-related adverse events [ Time Frame: 1 year ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Colorectal or Breast Cancer undergoing Neoadjuvant or Adjuvant pharmacological treatment.
Criteria

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

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): NCT03759548


Locations
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Brazil
Rede Mater Dei de Saúde - Hospital Integrado do Câncer Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30180080
Contact: Bernardo Coelho, MD    +5531987716731    bernardolevindo@hotmail.com   
Principal Investigator: Maria Isabel Toulson Davisson Correia, PhD         
Sub-Investigator: Bernardo Faria Levindo Coelho, MD         
Sponsors and Collaborators
Federal University of Minas Gerais
Mater Dei Hospital, Brazil

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Responsible Party: Maria Isabel Toulson Davisson Correia, Clinical Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03759548     History of Changes
Other Study ID Numbers: CAAE: 91570318.5.0000.5149
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual-level informations will not be available in order to preserve patient's identity.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais:
Nutritional Status
Colorectal Cancer
Breast Cancer
Pharmacological Treatment
Toxicity
Quality of Life
Additional relevant MeSH terms:
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Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases