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| ID | Type | Description | Link |
|---|---|---|---|
| CE3650 | Other Identifier | Comité d'Ethique |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bowel symptoms & QoL assessment | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At study completion, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At study completion, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sarcopenia prevalence and its association with PRT20 and QLQ-C30 score Delta. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Anderlecht | Brussels Capital | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28640871 | Background | 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. | |
| 16814954 | Background |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| D007410 | Intestinal Diseases |
| D003967 | Diarrhea |
| D044342 | Malnutrition |
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Quality of life questionnaires and dietician advice before and at the end of treatment.
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| At study completion, an average of 4 months |
| Malnutrition prevalence and its association with PRT20 and QLQ-C30 score Delta. | 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:
| 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. | 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. | 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 | 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 | 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 |
| 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. |
| 24067488 | Background | 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. |
| 29360138 | Background | 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. |
| 28739383 | Background | 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. |
| 30157890 | Background | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D001519 | Behavior |