Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The incidence and change of endocrine dysfunction.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Drug omission (Drug)
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.
干预措施: Control group (Other)
结局指标
主要结局
The incidence and change of endocrine dysfunction.
时间窗: 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).
次要结局
- Cost change.(36 months)
- 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.)
研究者
Vanessa Armenio Scontre
Principal Investigator
Instituto do Cancer do Estado de São Paulo
