Clinical trial NCT03759548: Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer
Official title: Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutritional Status
Colorectal Cancer
Breast Cancer
Keywords: Nutritional Status
Colorectal Cancer
Breast Cancer
Pharmacological Treatment
Toxicity
Quality of Life
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Mater Dei Hospital, Brazil
First posted: 2018-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Colorectal or Breast Cancer undergoing Neoadjuvant or Adjuvant pharmacological treatment.

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.

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.

Eligibility 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

Primary outcomes:
measure: Impact in Quality of Life during pharmacological treatments
timeFrame: 1 year
Secondary outcomes:
measure: Pharmacological treatment-related adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Rede Mater Dei de Saúde - Hospital Integrado do Câncer
state: Minas Gerais
Study officials:
References: