An interventional study of Adapted Physical Activity and Dietetic and conventional management in Prostate Cancer, sponsored by Centre Leon Berard. Recruiting at 5 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Other
The primary objective of this study is to evaluate the impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) ans dietetic on the reduction of interventions number on rectal volume (laxative or probe).
The secondary objectives are to evaluate the contribution of Patient's Therapeutic Education (PTE) between the 2 arms on repositionnind during the radiotherapy session, the gastrointestinal toxicity, the need to use laxative or transit regulating treatment or techniques, the quality of life, the undernutrition and food intake, the evolution in eating/hydratation and physical habits.
For the experimetal arm, the satisfaction and the compliance with PTE program will be evaluated, as well as the need of additionnal use of dietary and APA consultations.
Prostate cancer is the 3rd cause of cancer mortality in patient aged over 50 years. Radiotherapy treatment plans require specific conditions:
To allow reproductibility of target volume positioning at each radiotherapy session, it's recommended to have an empty rectum at the time of the radiotherapy preparation scan, and to check repletion before each session.
It's recommended that the patient has a comfortably full bladder to limit the volume of irradiated bladder mucosa. The radiotherapy teams don't have any recommendations concerning the rectum and manage this problem session by session, according to the repositioning Imaging of the current day.
According to a pilot study carried out in 2017 in the radiotherapy department of the Léon Bérard center, an intervention for a dilated rectum (probe or laxative) was necessary for an average of 25% of session per patient.
These rectal problems can be partly explained by the age (60-80 years) and sedentary lifestyle of patients with prostate cancer. Physical activities, adapted hydratation and changes in eating habits are an integral part of the constipation and flatulence prevention.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 216 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
I1: Age >= 18 years old.
I2: Patient with prostatic adenocarcinoma with indication for first-line or post-operative radiotherapy (adjuvant or biologic recurrence).
I3: Patient able to practice a physical activity (certificate of aptitude for adapted physical activity).
I4: Life expectancy greater than 6 months.
I5: Absence of chronic inflammatory intestinal disease or intestinal surgery.
I6: Signed informed consent.
I7: Patient covered by a medical insurance.
I8. At least 20 sessions of radiotherapy planned
Exclusion Criteria:
E1: Patient does not understand and cannot read French.
E2: Patient followed for a psychiatric pathology or presenting cognitive disorders.
E3: Inability to comply with study follow-up goegraphical, social or psychological reasons.
E4: Patient requiring tutorship or curatorship or patient deprived of liberty.
E5: Participation to another clinical trial which may interfere with principal Endpoint assessment.
Educational diagnosis prior radiotherapy and participation to Patient Therapeutics Education (PTE) in Adapted Physical Activity (APA) and dietetic sessions. In addition to conventional support (dietary and hydration advice).
Other: Adapted Physical Activity and Dietetic
Dietary and hydration advices
Other: conventional management
session in addtion conventional management dietetic, hydratation and physical activity
Also known as: Follow-up of Adapted Physical Activity and Dietetic Hydratation
Dietary and hydratation advices according to the recommendations
Also known as: conventional management dietary and hydratation
Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum
Number of uninstallation during the radiotherapy session
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency
Rate of patients never uninstalled compared to patients uninstalled during prostate's radiotherapy
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity
Acute gastrointestinal toxicity ≥ grade 2 (NCI- CTCAE V5)
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques
Prescribed laxatives or transit regulation treatments or techniques
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life
Using European Organisation for Research and Treatment of Cancer - Core Quality of life questionnaire (QLQC30) (Evaluation of patient's quality of life during the last 7 days - From 4 \[worse reply\] to 1 \[better reply\])
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Collection of patients' weight (kg)
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Collection of patients' weight (kg)
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Using Socio Economic Factor Index scale (SEFI) (Scale from 10 \[I ate my entire meal\] to 0 \[I did not eat anything\])
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Using Socio Economic Factor Index scale (SEFI) (Scale from 10 \[I ate my entire meal\] to 0 \[I did not eat anything\])
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Using the "Eating and hydration habits questionnaire"
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Using the "Eating and hydration habits questionnaire"
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the evolution in eating habits
Using the "Eating and hydration habits questionnaire"
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the evolution in hydratation habits
Using the "Eating and hydration habits questionnaire"
Time frame: An average of 4 months
Evaluate the contribution of Patient's Therapeutic Education on the evolution in APA habits
Using International Physical Activity Questionnaire (IPAQ) (Description of the physical activity during the last 7 days)
Time frame: An average of 4 months
Evaluate patient's satisfaction with Patient's Therapeutic Education program (experimental arm)
Using satisfaction questionnaire (scale from 1 \[worse evaluation\] to 4 \[better evaluation\])
Time frame: An average of 4 months
Evaluate the compliance to APA session recommendations
Daily collection of steps numbers
Time frame: An average of 4 months
Evaluate the compliance to APA session recommendations
Evaluation during phone calls every 15 days
Time frame: An average of 4 months
Evaluate the number of patients requiring additional dietetic session
Evaluation during phone calls every 15 days
Time frame: An average of 4 months
Evaluate the number of patients requiring additional APA session
Evaluation during phone calls every 15 days
Time frame: An average of 4 months
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