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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Drug omission; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01246000
      • Vanessa Scontre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Drug omission; Drug omission. In the experimental group, dexamethasone will be omitted from the second application of paclitaxel.
Active Comparator: 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.	Other: Control group; No drug omission. In the control group, dexamethasone will not be omitted in the second application of paclitaxel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers evaluation.	Evaluate inflammatory markers that may be related to endocrine syndromes resulting from the overuse of corticosteroids, and determine their correlation with the occurrence of endocrine syndromes.	36 months
Evaluation of the correlation between inflammatory markers and corticosteroid dose.	To assess the correlation between the serum level of inflammatory marker and the total dose of corticosteroids administered.	36 months
Progression Free Survival.	Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause.	36 months
Change of Quality of life.	To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3) during chemotherapy. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.	On the first day of treatment, on the first day of week 3 and on the last day of the final treatment.
Cost change.	Analyze the treatment cost reduction omitting the use of dexamethasone in these patients.	36 months

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Vanessa A Scontre, MD, Instituto do Cancer do Estado de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; dexamethasone; endocrinological changes
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NP 1521/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No