Nutritional StatusNCT03759548
Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer
An observational study of Nutritional Status and Colorectal Cancer, run by Federal University of Minas Gerais at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Status, Colorectal Cancer, Breast Cancer
- What is being tested?
- Assessment of nutritional status
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Colorectal or Breast Cancer undergoing Neoadjuvant or Adjuvant pharmacological treatment.
Who may be able to join
- Pathological diagnosis of Colorectal Cancer or Breast Cancer
- Must have Performance Status to undergo surgery and pharmacological treatment (Adjuvant or Neoadjuvant treatment)
Who cannot join
- Non-operable patients
- Pacientes with poor Performance Status Eastern Cooperative Oncology Group (PS ECOG) >2
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rede Mater Dei de Saúde - Hospital Integrado do Câncer
Belo Horizonte, Minas Gerais, 30180080
Bernardo Coelho, MD, +5531987716731, bernardolevindo@hotmail.com
Maria Isabel Toulson Davisson Correia, PhD
About this study
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.
Read the 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.
- Conditions
- Nutritional Status, Colorectal Cancer, Breast Cancer
- Being tested
- Assessment of nutritional status
- Keywords
- Nutritional Status, Colorectal Cancer, Breast Cancer, Pharmacological Treatment, Toxicity, Quality of Life
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of nutritional statusOther
Observational study. Assessment of nutritional status.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Breast Cancer's patients undergoing pharmacological treatments prior or after surgery. Receives: Other: Assessment of nutritional status | |
| Colorectal Cancer | Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery. Receives: Other: Assessment of nutritional status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (1)
Pharmacological treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Nov 2018
- Primary completion1 Dec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Mater Dei Hospital, Brazil
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759548
- Sponsor's protocol ID
- CAAE: 91570318.5.0000.5149
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level informations will not be available in order to preserve patient's identity.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer
- ClinicalTrials.gov ID
- NCT03759548
- Acronym / sponsor ID
- CAAE: 91570318.5.0000.5149
- Conditions
- Nutritional Status, Colorectal Cancer, Breast Cancer
- Keywords
- Nutritional Status, Colorectal Cancer, Breast Cancer, Pharmacological Treatment, Toxicity, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Mater Dei Hospital, Brazil
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Other: Assessment of nutritional statusBreast Cancer's patients undergoing pharmacological treatments prior or after surgery. |
| Colorectal Cancer | – | Other: Assessment of nutritional statusColorectal Cancer's patients undergoing pharmacological treatments prior or after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Colorectal or Breast Cancer undergoing Neoadjuvant or Adjuvant pharmacological treatment.
Key inclusion criteria (2 listed)
- Pathological diagnosis of Colorectal Cancer or Breast Cancer
- Must have Performance Status to undergo surgery and pharmacological treatment (Adjuvant or Neoadjuvant treatment)
Key exclusion criteria (2 listed)
- Non-operable patients
- Pacientes with poor Performance Status Eastern Cooperative Oncology Group (PS ECOG) >2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of nutritional statusObservational study. Assessment of nutritional status. | Other | Breast Cancer, Colorectal Cancer |
Primary outcome
Impact in Quality of Life during pharmacological treatments
Time frame: 1 year
Impact in Quality of Life as assessed by European Organization for Research Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)
1 secondary outcome
Pharmacological treatment-related adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: No. Individual-level informations will not be available in order to preserve patient's identity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rede Mater Dei de Saúde - Hospital Integrado do Câncer
Belo Horizonte, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status and Colorectal Cancer, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact in Quality of Life during pharmacological treatments (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.