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Completed

NCT Number: NCT01960881

Evaluation of Diet and Exercise in Prostate Cancer Patients

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Study type

Observational

Primary location

Exdeo Clinical Research Inc /ID# 116040, Abbotsford British Columbia, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)

    Time frame: From Month 0 to Month 18

    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.

  2. Change in exercise duration

    Time frame: From Month 0 to Month 18

    Assessed at every visit what was the amount of various types of exercise performed in the previous month.

  3. Change in dietary habits

    Time frame: From Month 0 to Month 18

    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.

Secondary outcomes

  1. Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)

    Time frame: From Month 0 to follow-up visits 3,6 and 12 months

    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.

  2. Change in weight

    Time frame: From Month 0 to Month 18

    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  3. Change in Body Mass Index (BMI)

    Time frame: From Month 0 to Month 18

    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.

  4. Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI)

    Time frame: From Month 0 to Month 18

    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.

  5. Changes in the sexual function using the International Index of Erectile Function (IIEF-5)

    Time frame: From Month 0 to Month 18

    An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction (for patients enrolled prior to protocol amendment 2)

  6. Number of patients with Adverse Events

    Time frame: From Month 0 to Month 18

    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

  7. Changes in the patient's medical condition

    Time frame: From Month 0 to Month 18

    Any change in the patient's medical condition including new onset or worsening of medical conditions.

  8. Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments.

    Time frame: From Month 0 to Month 18

    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.

  9. Leuprolide Acetate Utilization

    Time frame: From Month 0 to Month 18

    Utilization of Leuprolide Acetate will be assessed.

  10. Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2)

    Time frame: From Month 0 to Month 18

    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

  11. Caregiver Quality of Life (for patients enrolled under protocol amendment 1)

    Time frame: From Month 0 to Month 18

    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.

  12. Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1)

    Time frame: Up to Month 18

    Measured with a self-reported questionnaire.

  13. Lupron Cares Patient Support Program

    Time frame: Up to Month 18

    Enrollment and use will be assessed for the patient support program.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium

Registry information

Official study title

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

Acronym: CRONOS II

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2013
Registry last updated
Aug 9, 2022

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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