Clinical trial NCT04350229: Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer
Official title: Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
endocrinological changes
dexamethasone
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment for patients with high-risk breast cancer diagnoses is based on chemotherapy drugs with side effects. Dexamethasone is a drug that is part of the arsenal of pre-chemotherapy medications to prevent adverse events resulting from treatment, however common endocrine pathological conditions resulting from high doses of this corticoid are clinically evident in these individuals. The aim of this study is to evaluate the omission of corticosteroid doses as a pre-medication in cancer treatment after the second week of treatment with taxane in a curative setting.

Detailed description: Treatment for patients with diagnoses of high-risk breast cancer is based on chemotherapy drugs such as anthracyclines and taxanes and its main side effects described are cardiac toxicity and hypersensitivity and / or allergic reactions, respectively. Dexamethasone is a drug that is part of the arsenal of pre-chemotherapy medications to prevent adverse events resulting from treatment, however common endocrine pathological conditions resulting from high doses of this corticoid are clinically evident in these individuals.

These changes certainly have a negative impact on the patient's quality of life, however, with early recognition and the treatment of hypercortisolemia, we can lead to a reduction in morbidity and mortality in cancer patients.

The objective of this study is to evaluate whether the omission of corticosteroid doses as pre-medication in cancer treatment after the second week of treatment with taxane in a setting with curative intent can prevent or decrease the incidence of endocrinological changes, and what is its impact on treatment and on quality of life of the patient.

This is a prospective, randomized clinical study, without blinding as a research strategy used to increase the validity of clinical trials that evaluate the effect of interventions (eg, drugs or exercise). The process involves randomly assigning participants to an intervention group or to a control group and requires that participants have an equal chance of being allocated to either group.

Will be recruited 86 patients diagnosed with breast cancer with indication for neoadjuvant or adjuvant treatment with the standard ICESP protocol.

Eligibility criteria: Inclusion Criteria:

* Patients from the oncology services of ICESP and its Osasco unit.
* Over 18 years of age.
* Diagnosed with breast cancer who will be treated with an ACT Icesp scheme in the setting with curative intent (neoadjuvant and adjuvant).

Exclusion Criteria:

* Patients with significant cognitive impairment that prevents the questionnaire from being applied.
* Patients who are not fluent in Portuguese, or illiterate, who did not sign the ICF.
* ECOG 3 and KPS \<70%.
* Metastatic patients, with the presence of other important morbidities that may interfere with laboratory findings.
* Patients with chronic use of steroidal and non-steroidal anti-inflammatory drugs.

Primary outcomes:
measure: The incidence and change of endocrine dysfunction.
timeFrame: 36 months
Secondary outcomes:
measure: Inflammatory markers evaluation.
timeFrame: 36 months
measure: Evaluation of the correlation between inflammatory markers and corticosteroid dose.
timeFrame: 36 months
measure: Progression Free Survival.
timeFrame: 36 months
measure: Change of Quality of life.
timeFrame: On the first day of treatment, on the first day of week 3 and on the last day of the final treatment.
measure: Cost change.
timeFrame: 36 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Vanessa Scontre
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Vanessa A Scontre, MD
role: PRINCIPAL_INVESTIGATOR
References: