Clinical trial NCT05880446: PROstate CAncer Radiotherapy - Bowel Quality of Life (PROCAR-BQ)
Official title: PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Radiotherapy Side Effect
Bowel Dysfunction
Quality of Life
Keywords: Prostate Cancer
Radiotherapy Side Effect
Radiation Toxicity
Bowel Dysfunction
Pelvic Radiation Disease
Diarrhea
Radiation Proctitis
Radiation enteritis
Quality of Life
Malnutrition
Sarcopenia
Diet
Physical activity
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 41
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quality of life questionnaires and dietician advice before and at the end of treatment.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Delta of EORTC Proctitis Module (PRT20) score
timeFrame: At study completion, an average of 4 months
Secondary outcomes:
measure: Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score
timeFrame: At study completion, an average of 4 months
Other outcomes:
measure: Sarcopenia prevalence and its association with PRT20 and QLQ-C30 score Delta.
timeFrame: At study completion, an average of 4 months
measure: Malnutrition prevalence and its association with PRT20 and QLQ-C30 score Delta.
timeFrame: At study completion, an average of 4 months
measure: Max Dose on Bowel Bag, Sigmoid & Rectum and its association with PRT20 and QLQ-C30 score Delta.
timeFrame: At study completion, an average of 4 months
measure: Mean Dose on Bowel Bag, Sigmoid & Rectum and its association with PRT20 and QLQ-C30 score Delta.
timeFrame: At study completion, an average of 4 months
measure: Low Diet Quality Index prevalence and its association with PRT20 and QLQ-C30 Delta
timeFrame: At study completion, an average of 4 months
measure: Low Physical Activity Level prevalence and its association with PRT20 and QLQ-C30 Delta
timeFrame: At study completion, an average of 4 months
Locations:
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
state: Bruxelles
Study officials:
References:
citation: Delobel JB, Gnep K, Ospina JD, Beckendorf V, Chira C, Zhu J, Bossi A, Messai T, Acosta O, Castelli J, de Crevoisier R. Nomogram to predict rectal toxicity following prostate cancer radiotherapy. PLoS One. 2017 Jun 22;12(6):e0179845. doi: 10.1371/journal.pone.0179845. eCollection 2017.
citation: Heemsbergen WD, Peeters ST, Koper PC, Hoogeman MS, Lebesque JV. Acute and late gastrointestinal toxicity after radiotherapy in prostate cancer patients: consequential late damage. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):3-10. doi: 10.1016/j.ijrobp.2006.03.055. Epub 2006 Jul 11.
citation: Andreyev HJ, Benton BE, Lalji A, Norton C, Mohammed K, Gage H, Pennert K, Lindsay JO. Algorithm-based management of patients with gastrointestinal symptoms in patients after pelvic radiation treatment (ORBIT): a randomised controlled trial. Lancet. 2013 Dec 21;382(9910):2084-92. doi: 10.1016/S0140-6736(13)61648-7. Epub 2013 Sep 23.
citation: Lawrie TA, Green JT, Beresford M, Wedlake L, Burden S, Davidson SE, Lal S, Henson CC, Andreyev HJN. Interventions to reduce acute and late adverse gastrointestinal effects of pelvic radiotherapy for primary pelvic cancers. Cochrane Database Syst Rev. 2018 Jan 23;1(1):CD012529. doi: 10.1002/14651858.CD012529.pub2.
citation: Sini C, Noris Chiorda B, Gabriele P, Sanguineti G, Morlino S, Badenchini F, Cante D, Carillo V, Gaetano M, Giandini T, Landoni V, Maggio A, Perna L, Petrucci E, Sacco V, Valdagni R, Rancati T, Fiorino C, Cozzarini C. Patient-reported intestinal toxicity from whole pelvis intensity-modulated radiotherapy: First quantification of bowel dose-volume effects. Radiother Oncol. 2017 Aug;124(2):296-301. doi: 10.1016/j.radonc.2017.07.005. Epub 2017 Jul 21.
citation: Halkett GKB, Wigley CA, Aoun SM, Portaluri M, Tramacere F, Livi L, Detti B, Arcangeli S, Lund JA, Kristensen A, McFadden N, Grun A, Bydder S, Sackerer I, Greimel E, Spry N; EORTC Quality of Life Group. International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study. Radiat Oncol. 2018 Aug 29;13(1):162. doi: 10.1186/s13014-018-1107-x.