Effect of Synbiotics on Gastrointestinal Chemotherapy Symptoms

Not Applicable

Not yet recruiting

Conditions: Solid tumours
Cancer - Any cancer

Registration Number: ACTRN12621000234819

Lead Sponsor: KFSU Pty Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

•Adult patients with solid tumour cancers starting chemotherapy treatment.
•Age range: 50-75 years, with a life expectancy of more than 12 months.
•Able to take food and fluid orally.
•Able to comply with all study requirements.

Exclusion Criteria

•Active infection treated by antibiotic therapy.
•Ileostomy.
•Hypersensitivity to study synbiotics.
•History of major psychiatric illness
•Any significant psychological, familial, sociological or geographical conditions, which could potentially hamper compliance with study protocol and follow-up schedule.
•Participants with low English proficiency.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of chemotherapy induced gastrointestinal (GI) complications such as vomiting, diarrhoea, constipation, mucositis and other symptoms such as chest pain, dyspnoea, fatigue etc.<br>This is a composite primary outcome measurable as change in FACT-C scores.[1. Baseline (before chemotherapy).<br>2. Two weeks post each chemotherapy cycle.<br>3. At four weeks post each chemotherapy cycle. ];Quality of life will be assessed using the FACT-C questionnaire. FACT-C is a well-being questionnaire which includes questions about the patient’s physical, social, emotional and functional well-being as well as colorectal symptoms including diarrhoea on a scale of 0 to 4. <br>[1. Baseline (before chemotherapy).<br>2. Two weeks post each chemotherapy cycle.<br>3. At four weeks post each chemotherapy cycle. ]

Secondary Outcome Measures

Name	Time	Method
umber of patients that discontinued chemotherapy due to diarrhoea. This data will be accessed through patient medical records.[1. Two weeks post each chemotherapy cycle.<br>2. At four weeks post each chemotherapy cycle. ];LPS levels will be measured by using serum assays.[1. Baseline (before chemotherapy).<br>2. Two weeks post each chemotherapy cycle.<br>3. At four weeks post each chemotherapy cycle. ];Bristol stool score (change in stool consistency).[1. Baseline (before chemotherapy).<br>2. Two weeks post each chemotherapy cycle.<br>3. At four weeks post each chemotherapy cycle. ]