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

F

Federal University of Minas Gerais

Status

Unknown

Conditions

Breast Cancer
Nutritional Status
Colorectal Cancer

Treatments

Other: Assessment of nutritional status

Study type

Observational

Funder types

Other

Identifiers

NCT03759548
CAAE: 91570318.5.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Breast Cancer
Description:
Breast Cancer's patients undergoing pharmacological treatments prior or after surgery.
Treatment:
Other: Assessment of nutritional status
Colorectal Cancer
Description:
Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery.
Treatment:
Other: Assessment of nutritional status

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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