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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Colorectal Cancer; Nutritional Status
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30180080
      • Recruiting
      • Rede Mater Dei de Saúde - Hospital Integrado do Câncer
      • Contact: Bernardo Coelho, MD; Phone Number: +5531987716731; Email: bernardolevindo@hotmail.com
      • Principal Investigator: Maria Isabel Toulson Davisson Correia, PhD
      • Sub-Investigator: Bernardo Faria Levindo Coelho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Colorectal or Breast Cancer undergoing Neoadjuvant or Adjuvant pharmacological treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacological treatment-related adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 year

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Mater Dei Hospital, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer; Quality of Life; Colorectal Cancer; Toxicity; Nutritional Status; Pharmacological Treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Breast Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: CAAE: 91570318.5.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual-level informations will not be available in order to preserve patient's identity.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No