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

• Conditions: Nutritional Status; Colorectal Cancer; Breast Cancer
• Interventions: Other: Assessment of nutritional status

• Registration Number: NCT03759548
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-01
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-30
• Last Update Posted: 2018-11-30
• Primary Completion: 2019-12-01
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer	Assessment of nutritional status	Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery.
Breast Cancer	Assessment of nutritional status	Breast Cancer's patients undergoing pharmacological treatments prior or after surgery.

Primary Outcome Measures

Name	Time	Method
Impact in Quality of Life during pharmacological treatments	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

Name	Time	Method
Pharmacological treatment-related adverse events	1 year	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Rede Mater Dei de Saúde - Hospital Integrado do Câncer; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil