PROstate CAncer Radiotherapy - Bowel Quality of Life (PROCAR-BQ)

Jules Bordet Institute41 enrolled

Overview

This is a prospective pilot study to evaluate the mean increase of bowel symptoms after pelvic radiotherapy (RT) in prostate cancer (PCa) patient using the validated \& newly translated EORTC-QLQ PRT20 module.

Questionnaires (QLQ-C30 and PRT20 modules) will be held to patients at the beginning and at the end of RT (4 weeks) to evaluate the mean increase of lower GI symptoms and decrease in overall QoL after pelvic RT. For exploratory objectives, GLIM (Global Leadership Initiative on Malnutrition) criteria for malnutrition diagnosis, a 24h recall and DQI-I calculation will be assessed by the PI before the start of RT. CT sim \& dosimetry will be analyse by the PI before treatment to evaluation the body composition and the max and mean dose received by the bowel, the sigmoid and the rectum. A Polar watches will be loaned to the patient by the PI at the CT sim appointment to record patient's daily movement for two weeks (usual waiting time between CT and treatment) and recovered on the first day of treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer Radiotherapy Side Effect Bowel Dysfunction Quality of Life

Interventions

Bowel symptoms & QoL assessmentOTHER

QoL and bowel symptoms questionnaires will be held to patients, anthropomorphic measurement, handgrip test, physical activity level and usual diet quality of the patient will be assessed.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * Men with PCa which are candidate for pelvic radiotherapy (RT) with or without previous surgery, with or without concomitant hormonotherapy (HT), Performance status (PS) 0-2 (all patient able to undergo RT treatment), of all age, elderly included. Exclusion Criteria: * Previous RT to the pelvis * Diagnosed Inflammatory Bowel Disease (IBD), celiac disease * Severe GI symptoms before the beginning of RT (Grade \> 2 according to CTCAE grading system) * Obvious cognitive impairment, * Inability to understand French/English and no contact person able to accompany and translate.

Locations (1)

Institut Jules Bordet

Anderlecht, Brussels Capital, Belgium

Outcomes

Primary Outcomes

Mean Delta of EORTC Proctitis Module (PRT20) score

Mean Delta between the end and the beginning of RT (4 weeks) in PRT20 score (Min 18, Max 72, higher scores mean worse outcome)

Time frame: At study completion, an average of 4 months

Secondary Outcomes

Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score

Mean Delta between the end and the beginning of RT (4 weeks) in C30 score (For symptoms: Min 28, Max 112, higher scores mean worse outcome; For general status: Min 2, Max 14, higher scores mean better outcome)

Time frame: At study completion, an average of 4 months

Data from ClinicalTrials.gov

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