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

NCT03759548 | Unknown DMC

• 1 other identifier: CAAE: 91570318.5.0000.5149
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Status; Colorectal Cancer; Breast Cancer

Keywords

Nutritional Status; Colorectal Cancer; Breast Cancer; Pharmacological Treatment; Toxicity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacological treatment-related adverse events

  1 year

Study Arms (2)

Breast Cancer

Breast Cancer's patients undergoing pharmacological treatments prior or after surgery.

Other: Assessment of nutritional status

Colorectal Cancer

Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery.

Other: Assessment of nutritional status

Interventions

Assessment of nutritional status OTHER

Observational study. Assessment of nutritional status.

Breast Cancer; Colorectal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Pathological diagnosis of Colorectal Cancer or Breast Cancer
• Must have Performance Status to undergo surgery and pharmacological treatment (Adjuvant or Neoadjuvant treatment)

You may not qualify if:

• Non-operable patients
• Pacientes with poor Performance Status Eastern Cooperative Oncology Group (PS ECOG) \>2

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Mater Dei Hospital, Brazil: collaborator

Study Sites (1)

Rede Mater Dei de Saúde - Hospital Integrado do Câncer

Belo Horizonte, Minas Gerais, 30180080, Brazil

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 30, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)