Effect of Pelvic Radiotherapy on the Intestinal Microbiome and Metabolome

NCT04995809CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

The Christie NHS Foundation Trust

Enrollment

18

Start Date

2021-07-05

Completion Date

2023-07-21

Study Type

OBSERVATIONAL

Official Title

Investigating the Effect of Pelvic Radiotherapy on the Intestinal Microbiome and Metabolome to Improve the Detection and Management of Gastrointestinal (GI) Toxicity.

Conditions

Urinary Bladder NeoplasmsUterine Cervical NeoplasmsEndometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

Inclusion Criteria:

* Pelvic radiotherapy-cervix/endometrial/bladder cancer.
* ≥18 years.
* Able to consent.
* Able to complete questionnaires.

Exclusion Criteria:

* Pre-existing GI disease
* Abdominopelvic surgery within preceding 4 weeks

Outcome Measures

Primary Outcomes

Rate of recruitment

Recruitment rates: can we achieve sufficient recruitment to the study? Are patients willing to participate?

Time frame: 12 months

Acceptability of recruitment

Acceptability of recruitment process to patient cohort measured using internally generated non-validated questionnaire led by the research nurse

Time frame: 12 months

Patient experience of study

Experience of the study process by patient cohort measured using internally generated non-validated questionnaire led by the research nurse

Time frame: 6 months

Stool sample collection

Practicality and acceptability of obtaining stool samples for patient cohort measured using internally generated non-validated questionnaire led by the research nurse

Time frame: 6 months

Attrition rates

Rate of patient leaving the study before completing

Time frame: 18 months

Reason for attrition

Reason for patient leaving the study before completing

Time frame: 18 months

Secondary Outcomes

Acceptability of questionnaires/food diaries

Acceptability of questionnaires and food diaries to patient cohort measured using internally generated non-validated questionnaire led by the research nurse

Time frame: 6 months

Completion of information

Proportion of patients who complete the study eg rate of attrition of patients and rate of missing data items

Time frame: 6 months

The number of participants required to take part in a larger multicentre trial which will identify microbiome/VOC profiles which confer risk of GI toxicity

To identify microbiome (diversity or composition) or VOCs profile that confers risk of GI-toxicity and that is associated with participants greater severity of GI-toxicity in response in response to radiotherapy in the acute and chronic phases

Time frame: 24 months

The number of participants required to take part in a larger multicentre trial which will identify potential therapeutic targets from metabolomic and microbiomic profiling

To use metabolomic and microbiomic profiling to further understand the pathophysiology of GI-toxicity to identify potential therapeutic targets for treatment and/or prevention, including dietary targets

Time frame: 24 months

Locations

Louise James, Manchester, United Kingdom