Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer

NCT ID: NCT04350229

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-27
• Study Completion Date: 2022-06-20

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXPERIMENTAL GROUP

In the experimental group, dexamethasone will be omitted from the second application of paclitaxel.

Pre-chemotherapy with the AC protocol: ondansetron 8mg and dexamethasone 10mg + Pre-chemotherapy with paclitaxel: ranitidine 50mg, ondansetron 8mg, diphenhydramine 50mg.

Group Type: EXPERIMENTAL

Drug omission

Intervention Type: DRUG

Drug omission. In the experimental group, dexamethasone will be omitted from the second application of paclitaxel.

CONTROL GROUP

Pre-chemotherapy with the AC protocol: ondansetron 8mg and dexamethasone 10mg + Pre-chemotherapy with paclitaxel: ranitidine 50mg, ondansetron 8mg, diphenhydramine 50mg and dexamethasone 10mg.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

No drug omission. In the control group, dexamethasone will not be omitted in the second application of paclitaxel.

Interventions

Drug omission

Drug omission. In the experimental group, dexamethasone will be omitted from the second application of paclitaxel.

Intervention Type: DRUG

Control group

No drug omission. In the control group, dexamethasone will not be omitted in the second application of paclitaxel.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Armenio Scontre

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa A Scontre, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de São Paulo

Locations

Vanessa Scontre

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NP 1521/19

Identifier Type: -

Identifier Source: org_study_id