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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759548
• Other study ID #: CAAE: 91570318.5.0000.5149
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Nutritional Status

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