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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nutritional Status, Colorectal Cancer, Breast Cancer

Intervention / Treatment
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* Other: Assessment of nutritional status


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer<br>Breast Cancer's patients undergoing pharmacological treatments prior or after surgery. | Other: Assessment of nutritional status<br>* Observational study. Assessment of nutritional status.<br>|
| Colorectal Cancer<br>Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery. | Other: Assessment of nutritional status<br>* Observational study. Assessment of nutritional status.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional Status, Colorectal Cancer, Breast Cancer, Pharmacological Treatment, Toxicity, Quality of Life