The impact of low FODMAP diet on rectal volume variability during external beam radiation therapy of prostate cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012955

Enrollment

Registered

2017-08-29

Start date

2017-01-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Consultation explaining the diet to the patient

start of low-FODMAP diet

planning-CT

radiation therapy

input of pseudonymized imaging data (planning CT and cone-beam CTs)

establishing the testing parameters

mathematical evaluation of data Group 2: Historical control group (no diet), data collected in 2015-16

these historical data are now compared with the data from Arm 1.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Primary prostate cancer (primary or adjuvant radiotherapy), local recurrence or biochemical recurrence after resection; one planning-CT and three CBCTs from required periods available; written consent available

Exclusion criteria

Exclusion criteria: CBCTs not according to requirements; coincidental radiation of lymphatic drainage pathways; condition after rectal amputation; dose escalation by means of brachytherapy; chronic inflammatory bowel diseases; opioid intake

Design outcomes

Primary

Measure	Time frame
Volume and Variability of interfractional rectal (wall) volumes	—

Secondary

Measure	Time frame
a) Overlapping volume of the rectal (wall) with PTV; b) Occurrence of gastrointestinal symptoms	—

Countries

Germany

Contacts

Public ContactConstantinos Zamboglou

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

constantinos.zamboglou@uniklinik-freiburg.de+49 761 270-94610

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 19, 2026