Effects of dietary intervention on toxicity and quality of life in patients with Breast Cancer during chemotherapy treatment Neoadjuvant: randomized clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-3shhxs

Enrollment

Unknown

Registered

2018-11-12

Start date

2018-08-15

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast neoplasms

Interventions

This study is characterized by being a randomized clinical trial with parallel groups and 31 participants in each group, where the volunteers will be allocated to the groups by prior draw. The study w

Other

D004032

Q45.020.020

D011788

Eligibility

Sex/Gender

Female

Age

20 Years to 59 Years

Inclusion criteria

Inclusion criteria: Adult volunteers; age between 20 and 59 years; with diagnosis of breast cancer; with clinical and cognitive conditions to participate in the study stages; have not started any specific type of oncological treatment; have indication for neoadjuvant chemotherapy treatment; nutritional risk; not being in nutritional outpatient follow-up and have recent computed tomography of total abdomen.

Exclusion criteria

Exclusion criteria: Volunteers who are already undergoing some kind of cancer treatment; with AIDS diagnosis; non-cancerous liver diseases; tuberculosis; neurological disorders; at nutritional risk and with computed tomography prior to 60 days.

Design outcomes

Primary

Measure	Time frame
Quality of life assessment, verified through the application of validated questionnaires: QLQ C-30 and QLQ Br23 of the European Organization for Research and Treatment of Cancer (EORTC), based on the finding of a variation of at least 5% in pre and post-intervention measurements.	—

Secondary

Measure	Time frame
Toxicity assessment, verified through the application of specific questionnaires prepared by the researcher considering the Common Terminology Criteria for Adverse Events (CTCAE) classifications. The information will be obtained from records in medical records and self-report of the volunteers, during three cycles of chemotherapy, from the observation of a variation of at least 5% in the pre and post-intervention measurements.;Nutritional assessment, verified by means of food anamnesis, evaluation of biochemical exams collected in medical records, anthropometric evaluation, with measurement of weight, height and waist (CC) and hip circumference (QC) measurements and global subjective evaluation produced by the patient (ASG-PPP), from the observation of a variation of at least 5% in pre and post-intervention measurements.	—

Measure

Time frame

Toxicity assessment, verified through the application of specific questionnaires prepared by the researcher considering the Common Terminology Criteria for Adverse Events (CTCAE) classifications. The information will be obtained from records in medical records and self-report of the volunteers, during three cycles of chemotherapy, from the observation of a variation of at least 5% in the pre and post-intervention measurements.;Nutritional assessment, verified by means of food anamnesis, evaluation of biochemical exams collected in medical records, anthropometric evaluation, with measurement of weight, height and waist (CC) and hip circumference (QC) measurements and global subjective evaluation produced by the patient (ASG-PPP), from the observation of a variation of at least 5% in pre and post-intervention measurements.

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Countries

Brazil

Contacts

Public ContactAna Paula Fayh

Universidade Federal do Rio Grande do Norte - UFRN

apfayh@yhaoo.com.br+55(84)33422291

Outcome results

None listed

Source: REBEC (via WHO ICTRP)