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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03759548
Other study ID # CAAE: 91570318.5.0000.5149
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date December 2019

Study information

Verified date November 2018
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Assessment of nutritional status
Observational study. Assessment of nutritional status.

Locations

Country Name City State
Brazil Rede Mater Dei de Saúde - Hospital Integrado do Câncer Belo Horizonte Minas Gerais

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Minas Gerais Mater Dei Hospital, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact in Quality of Life during pharmacological treatments Impact in Quality of Life as assessed by European Organization for Research Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) 1 year
Secondary Pharmacological treatment-related adverse events Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 1 year
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