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NCT Number: NCT04350229

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanessa Scontre

São Paulo, 01246000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug omission

Drug

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

Control Group

Other

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

Primary outcomes

  1. The incidence and change of endocrine dysfunction.

    Time frame: 36 months

    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).

Secondary outcomes

  1. Inflammatory markers evaluation.

    Time frame: 36 months

    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.

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

    Time frame: 36 months

    To assess the correlation between the serum level of inflammatory marker and the total dose of corticosteroids administered.

  3. Progression Free Survival.

    Time frame: 36 months

    Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause.

  4. Change of Quality of life.

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

    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.

  5. Cost change.

    Time frame: 36 months

    Analyze the treatment cost reduction omitting the use of dexamethasone in these patients.

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Acronym: ALTEDEXAMAMA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2020
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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