ACTRN12620000832976终止未知
An exploratory study assessing effects of the circulating levels of obesity-related inflammatory cytokines on in vivo activity of cytochrome P450 enzymes in women receiving chemotherapy for breast cancer.
Canterbury District Health Board Research Office0 个研究点目标入组 12 人开始时间: 2020年8月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 12
研究概览
简要总结
Overall, in this study it was observed that: 1) body mass index increased significantly during chemotherapy; 2) the number of steps walked per day decreased significantly in the early stages of chemotherapy, and remained reduced throughout the study period; 3) three inflammation associated proteins increased in serum samples during chemotherapy; and 4) changes in liver enzyme activity varied between study participants, where majority of the participants had liver enzyme activity that remained stable during chemotherapy. We did not find a statistical association between inflammation and changes in body composition or physical activity levels. Interestingly, there was preliminary evidence for a relationship between increasing amounts of one inflammation protein and reducing activity in one of the liver enzymes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Women of age 18 or older.
- •Obese (BMI greater than or equal to 30 kg/m2) or normal weight (BMI ranging from 18.5-24.9 kg/m2) at diagnosis, according to BMI scoring.
- •Ability to understand and give written informed consent.
- •Ability to take oral medications.
- •Clinically defined stage II or III breast cancer.
- •Planned neoadjuvant or adjuvant chemotherapy with AC-T (cyclophosphamide, doxorubicin, paclitaxel).
- •Willing to wear FitBit One® throughout the selected cycles/doses of chemotherapy.
- •Willing to take probe drug cocktail and provide subsequent blood/urine samples.
- •No known sensitivity or contraindications to any of the cocktail components, including: midazolam, losartan, caffeine, omeprazole and dextromethorphan.
- •Have adequate end-organ function, as measured by:
- •Creatinine less than or equal to 2x Upper Limit of Normal (ULN)
- •Haemoglobin greater than 90 g/L
- •Systolic Blood Pressure greater than 90 mmHg
- •AST less than or equal to 3x ULN
- •ALTless than or equal to 3x ULN
- •Bilirubinless than or equal to 2x ULN
排除标准
- •Enrollment in any conflicting clinical trials.
- •Uncontrolled intercurrent illness including, but not limited to, on-going or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients that suffer from ongoing urinary incontinence and/or current use of a urinary catheter.
- •Cirrhosis as documented by liver biopsy, fibroscan, or a clinical history laboratory findings consistent with cirrhosis.
- •Impaired mobility due to disability or medical illness. For example:
- •oAmputation of either or both lower extremities
- •oRestricted to a wheelchair
- •Are known to have active infection with a viral hepatitis (e.g. Hepatitis B or C).
- •Unwilling to comply with requirements for recording times when the FitBit One® is not worn.
- •Any abnormal laboratory value or medical condition that would, in the investigators’ judgement, make the patient a poor candidate for the study.
- •Use of concurrent medications known to be inhibitors or inducers of the cytochrome P450 enzymes being studied. Weak inducers or inhibitors will be acceptable for inclusion.
研究者
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