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Completed

NCT Number: NCT05880446

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

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.

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Key information

Conditions

Prostate Cancer Atrophy Behavior Bowel Dysfunction Diarrhea Digestive System Diseases Gastrointestinal Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Male Urogenital Diseases Malnutrition Motor Activity Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Quality of Life Radiation Injuries Radiotherapy Side Effect Sarcopenia Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jules Bordet

Anderlecht, Brussels Capital, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bowel symptoms & QoL assessment

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

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

Acronym: PROCAR-BQ

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 30, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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