Evaluation of Diet and Exercise in Prostate Cancer Patients

Prostate Cancer Clinical Trial

— CRONOS II  

Official title:

Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed With Lupron (CRONOS II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960881
• Other study ID #: P14-096
• Status: Completed
• Start date: September 19, 2013
• Est. completion date: August 10, 2021

Study information

• Verified date: August 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.

Description:

This is a study utilizing a prospective cohort design. Patients with Prostrate cancer (PCa) who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 18 months with recommended assessments at 3, 6, 12 and 18 months after Day 1. Treatment of the patients and follow up will be according to the physicians' judgment, regional regulations and the product monograph.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1331
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

i. Adult = 18 years old

ii. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.

iii. Diagnosed with PCa.

iv. Prescribed Lupron as part of his treatment by his treating physician.

Exclusion Criteria:

i. Patient cannot or will not sign informed consent.

ii. Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of PCa.

iii. More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment.

iv. If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Exdeo Clinical Research Inc /ID# 116040	Abbotsford	British Columbia
Canada	The Male/Female Hlth and Res /ID# 116042	Barrie	Ontario
Canada	The Male/Female Hlth and Res /ID# 124295	Barrie	Ontario
Canada	Edward F.A. Woods Medicine Professional Corporation /ID# 120695	Belleville	Ontario
Canada	Jonathan Giddens Medicine /ID# 116023	Brampton	Ontario
Canada	Brantford Urology Research /ID# 116026	Brantford	Ontario
Canada	G. Kenneth Jansz Medicine Professional Corporation /ID# 116024	Burlington	Ontario
Canada	William R. Love, Medicine, Professional Corporation /ID# 116035	Burlington	Ontario
Canada	Clinique d'urologie /ID# 116019	Chicoutimi	Quebec
Canada	CISSS - Hôpital de Gatineau /ID# 131309	Gatineau	Quebec
Canada	CISSS de la Monteregie /ID# 116036	Greenfield Park	Quebec
Canada	CISSS de la Monteregie /ID# 124296	Greenfield Park	Quebec
Canada	CISSS de la Monteregie /ID# 134137	Greenfield Park	Quebec
Canada	QE II Health Sciences Centre /ID# 118941	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare /ID# 163973	Hamilton	Ontario
Canada	Southern Interior Medical Research /ID# 116025	Kelowna	British Columbia
Canada	Queen's University /ID# 137983	Kingston	Ontario
Canada	Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037	Laval	Quebec
Canada	Hopital Cite-de-la-Sante /ID# 130951	Laval	Quebec
Canada	London Health Sciences Center /ID# 118940	London	Ontario
Canada	DiCostanzo, Markham, CA /ID# 137272	Markham	Ontario
Canada	Jewish General Hospital /ID# 120416	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Center /ID# 141503	Montreal	Quebec
Canada	CHUM - Notre-Dame Hospital /ID# 137271	Montréal	Quebec
Canada	Mor Urology Inc /ID# 116027	Newmarket	Ontario
Canada	Stanley Flax Medical Prof Corp /ID# 116022	North York	Ontario
Canada	Fe/Male Health Centers /ID# 116020	Oakville	Ontario
Canada	Dr. Sean Pierre Medicine Professional Corporation /ID# 137986	Ottawa	Ontario
Canada	The Ottawa Hospital /ID# 132329	Ottawa	Ontario
Canada	Kawarth Urology Associates /ID# 116041	Peterborough	Ontario
Canada	The Medical Centre /ID# 128278	Peterborough	Ontario
Canada	Ultra-Med Research /ID# 116355	Pointe-claire	Quebec
Canada	Abara Medicine Professional Corporation /ID# 137270	Richmond Hill	Ontario
Canada	Saint John Regional Hospital /ID# 141302	Saint John	New Brunswick
Canada	1837206 Ontario Inc. /Id# 116038	Scarborough	Ontario
Canada	Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641	Scarborough	Ontario
Canada	Urology and Male Fertility /ID# 116043	Scarborough	Ontario
Canada	CHUS - Hopital Fleurimont /ID# 124275	Sherbrooke	Quebec
Canada	Northern Urology Centre /ID# 141391	Sudbury	Ontario
Canada	Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597	Toronto	Ontario
Canada	Princess Margaret Cancer Centre /ID# 137984	Toronto	Ontario
Canada	Toronto Urology Clin Study Grp /ID# 116044	Toronto	Ontario
Canada	Toronto West Urology Associates /ID# 116021	Toronto	Ontario
Canada	Toronto West Urology Associates /ID# 134134	Toronto	Ontario
Canada	Groupe De Recherche En Urologie De La Mauricie /ID# 116356	Trois-rivieres	Quebec
Canada	Ctr Sante et Services Sociaux /ID# 131230	Trois-rivières	Quebec
Canada	Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039	Val D'or	Quebec
Canada	Dr. J. Paul Whelan, Inc. /ID# 120415	Victoria	British Columbia
Canada	9120-1947 Quebec Inc. /ID# 129151	Westmount, Montreal	Quebec
Canada	CancerCare Manitoba /ID# 135976	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)	The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health.	From Month 0 to Month 18
Primary	Change in exercise duration	Assessed at every visit what was the amount of various types of exercise performed in the previous month.	From Month 0 to Month 18
Primary	Change in dietary habits	Assessed at every visit to what extent patient's complied with the Canadian Food Guide's recommendation for each of the four food group servings in the previous week.	From Month 0 to Month 18
Secondary	Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)	The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health.	From Month 0 to follow-up visits 3,6 and 12 months
Secondary	Change in weight	Change from Baseline is calculated as the post-Baseline value minus the Baseline value.	From Month 0 to Month 18
Secondary	Change in Body Mass Index (BMI)	BMI is a measure of body fat based on weight in relation to height. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.	From Month 0 to Month 18
Secondary	Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI)	A validated questionnaire designed to measure quality of life in patients with prostate cancer. It consists of 20 questions that assess urinary, sexual, bowel and hormonal function and impairment in patients with prostate cancer.	From Month 0 to Month 18
Secondary	Changes in the sexual function using the International Index of Erectile Function (IIEF-5)	An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction (for patients enrolled prior to protocol amendment 2)	From Month 0 to Month 18
Secondary	Number of patients with Adverse Events	Adverse events which lead to discontinuation of prescribed treatment under observation, will be coded according to the Medical Dictionary for Regulatory Activities (MeDRA) dictionary of terms	From Month 0 to Month 18
Secondary	Changes in the patient's medical condition	Any change in the patient's medical condition including new onset or worsening of medical conditions.	From Month 0 to Month 18
Secondary	Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments.	The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. A testosterone test checks the level of this male hormone (androgen) in the blood.	From Month 0 to Month 18
Secondary	Leuprolide Acetate Utilization	Utilization of Leuprolide Acetate will be assessed.	From Month 0 to Month 18
Secondary	Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2)	This will be ascertained with the Doctor-Patient Communication/Doctor's Questionnaire and the Doctor-Patient Communication/Patient's Questionnaire that are validated questionnaires developed by the College of Physicians of Quebec	From Month 0 to Month 18
Secondary	Caregiver Quality of Life (for patients enrolled under protocol amendment 1)	Measured with the Caregiver Quality of Life Index - Cancer scale (CQOLC). This is a 35 item questionnaire that measures the quality of life of individuals caring for cancer patients.	From Month 0 to Month 18
Secondary	Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1)	Measured with a self-reported questionnaire.	Up to Month 18
Secondary	Lupron Cares Patient Support Program	Enrollment and use will be assessed for the patient support program.	Up to Month 18

External Links

•   clinical study report synopsis