Exploring the effects of obesity-related inflammation on activity of chemotherapy metabolising liver proteins in breast cancer patients during treatment

Not Applicable

• Conditions: Breast cancer; Obesity; Cancer - Breast; Inflammatory and Immune System - Other inflammatory or immune system disorders; Diet and Nutrition - Obesity

• Registration Number: ACTRN12620000832976
• Lead Sponsor: Canterbury District Health Board Research Office

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-18
• Study Start: 2020-08-21
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

• Study Type: Observational
• Study Design: Not specified