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

NCT04350229 | Completed

• 1 other identifier: NP 1521/19
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; endocrinological changes; dexamethasone

Outcome Measures

Primary Outcomes (1)

• The incidence and change of endocrine dysfunction.

  To evaluate the incidence and reduction of endocrine dysfunction in breast cancer patients with the administration of lower doses of dexamethasone in the solutions of pre-chemotherapy medications with doxorubicin, cyclophosphamide and paclitaxel (standard protocol AC-T of the ICESP).

  36 months

Secondary Outcomes (5)

• Inflammatory markers evaluation.

  36 months

• Evaluation of the correlation between inflammatory markers and corticosteroid dose.

  36 months

• Progression Free Survival.

  36 months

• Change of Quality of life.

  On the first day of treatment, on the first day of week 3 and on the last day of the final treatment.

• Cost change.

  36 months

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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.

Drug: Drug omission

CONTROL GROUP

ACTIVE COMPARATOR

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

Other: Control group

Interventions

Drug omission DRUG

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

EXPERIMENTAL GROUP

Control group OTHER

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

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Vanessa Scontre

São Paulo, São Paulo, 01246000, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Vanessa A Scontre, MD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: March 27, 2020
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

BR (1)