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

March 19, 2024 updated by: Pauline De Bruyn, Jules Bordet Institute

PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Bruxelles
      • Anderlecht, Bruxelles, Belgium, 1070
        • Institut Jules Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bowel symptoms & QoL assessment
This single arm study represent a group a patient with prostate cancer who are candidate for pelvic radiotherapy. Patient reported outcomes on bowel toxicity and overall quality of life will be systematically assessed right before and after RT. Various potential predictive factors will be analysed.
Other: Bowel symptoms & QoL assessment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Delta of EORTC Proctitis Module (PRT20) score
Time Frame: At study completion, an average of 4 months
Mean Delta between the end and the beginning of RT (4 weeks) in PRT20 score (Min 18, Max 72, higher scores mean worse outcome)
At study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score
Time Frame: At study completion, an average of 4 months
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)
At study completion, an average of 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenia prevalence and its association with PRT20 and QLQ-C30 score Delta.
Time Frame: At study completion, an average of 4 months

Descriptive analysis of sarcopenia prevalence and its association with PRT20 and QLQ-C30 score Delta.

Men with L3 skeletal muscle index < 52.4 cm2/m2 will be classified as having sarcopenia. Skeletal muscle cross-sectional area (SMA) in cm2 at the third lumbar vertebra will be measured on the CT simulation (2 weeks before RT start) then normalized for stature to report the L3 skeletal muscle index (SMI) in cm2/m2. Hand-grip strength will be assessed as supportive measure the same day.
At study completion, an average of 4 months
Malnutrition prevalence and its association with PRT20 and QLQ-C30 score Delta.
Time Frame: At study completion, an average of 4 months

Descriptive analysis of GLIM (Global Leadership Initiative on Malnutrition) criteria for malnutrition diagnosis prevalence and its association with PRT20 and QLQ-C30 score Delta.

One of the three positive phenotypic criteria will lead to positive diagnosis of malnutrition:

  • >5 % weight loss within past 6 months (asked to patient during visit or compared to previous reports),
  • BMI < 20-22 (weight and height will be combined to report BMI in kg/m^2),
  • Reduces muscle mass by L3 skeletal muscle index < 52.4 cm2/m2 (skeletal muscle cross-sectional area in cm2 at the third lumbar vertebra will be measured by CT then normalized for stature to report the L3 skeletal muscle index in cm2/m2)
At study completion, an average of 4 months
Max Dose on Bowel Bag, Sigmoid & Rectum and its association with PRT20 and QLQ-C30 score Delta.
Time Frame: At study completion, an average of 4 months
Descriptive analysis of Dmax in Gray (Gy) on Bowel Bag, Sigmoid & Rectum on RT plan dosimetry and its association with PRT20 and QLQ-C30 score Delta.
At study completion, an average of 4 months
Mean Dose on Bowel Bag, Sigmoid & Rectum and its association with PRT20 and QLQ-C30 score Delta.
Time Frame: At study completion, an average of 4 months
Descriptive analysis of Dmean in Gray (Gy) on Bowel Bag, Sigmoid & Rectum on RT plan dosimetry and its association with PRT20 and QLQ-C30 score Delta.
At study completion, an average of 4 months
Low Diet Quality Index prevalence and its association with PRT20 and QLQ-C30 Delta
Time Frame: At study completion, an average of 4 months

Descriptive analysis of Low Diet Quality Index (DQI-I) prevalence and its association with PRT20 and QLQ-C30 score Delta.

DQI-I will be calculated from analysis of patient usual diet by the mean of a diet history and 24-h recall method before the start of RT and by it's conversion in nutritional values using composition tables. The continuous measure of the total DQI-I scores (Min 0, Max 100) of each patient will be categorized into quartiles (Very low, Low, Intermediate, High) and correlated to individual PRT20 and QLQ-C30 Delta in a descriptive manner.
At study completion, an average of 4 months
Low Physical Activity Level prevalence and its association with PRT20 and QLQ-C30 Delta
Time Frame: At study completion, an average of 4 months

Descriptive analysis of Low Physical Activity Level (PAL) prevalence and its association with PRT20 and QLQ-C30 score Delta.

Physical Activity Level will be recorded by the mean of Polar® Watches which will be loaned to the patient by the PI at the CT sim appointment for two weeks (usual waiting time between CT and treatment) and recovered on the first day of treatment
At study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Estimated)

March 29, 2024

Study Completion (Estimated)

March 29, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJB-PROCAR-BQ-2023
  • CE3650 (Other Identifier: Comité d'Ethique)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Bowel symptoms & QoL assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe