Interaction between inulin supplementation and cyclophosphamide therapy in patients with breast cancer

Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Breast cancer female patients will be suplemented with inulin (15g/day) upon cyclofosfamide therapy. This supplementation will be performed daily for 21 days, it will start the day after the administration of cyclofosfamide (regardless the combination with other chemotherapeutic agents or the therapy round). Inulin will be given as oral powder mixed in 250mL of water. In order to monitor adherence a food diary will be used as well as social networks (WhatsApp and Facebook). Moreover, hospital records of laboratory tests for albumin, transferrin and hemoglobin will be considered. CONDITION: Breast cancer Cachexy Chemotherapy toxicity PRIMARY OUTCOME: The change in GSTM1 mRNA expression in lymphocytes will be analyzed by qPCR. The change in GSTP1 mRNA expression in lymphocytes will be analyzed by qPCR. The change in GSTT1 mRNA expression in lymphocytes will be analyzed by qPCR. SECONDARY OUTCOME: Body fat distribution will be evaluated using a InBody230 bioimpedance apparatus. Body water content will be evaluated using a Inbody230 bioimpedance apparatus. Determination of body mass index will be performed using an InBody230 bioimpedance apparatus. Lean mass distribution will evaluated using a Inbody230 bioimpedance apparatus. Lean mass percentage will be determined using a InBody230 bioimpedance apparatus Percentage of body fat mass will be determined using a Inbody230 bioimpedance apparatus. Presence of gastrointestinal (nausea, vomit, diarrea) adverse events. This will be perfomed using "The service daily report of adverse events of the ISSEMYM Cancer Center". INCLUSION CRITERIA: Patients with clinical diagnosis of breast cancer, with score "0" according to the scale "Eastern Cooperative Oncology Group" (ECOG) . Patients who agree to participate and provide the required information. Patients with chemotherapy scheme with cyclophosphamide alone or in combination with methotrexate, 5‐fluorouracil and doxorubicin.
Epistemonikos ID: 58ee6cf86ead55a7e4458201d952c4ceea3a34d0
First added on: Aug 25, 2024