Clinical trial · Observational
PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training
A Prospective, Single Arm Study in Prostate Cancer Patients Managed With Androgen Deprivation Therapy to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training (ELIFIT)
NCT04057859CI-TRIAL-00056100ELIFITcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Changes in the patient quality of life (QoL) using the EORTC QLQ-C30
- timeFrame
- Month 0 to Month 36
- description
- The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient.
- measure
- Changes in the patient quality of life (QoL) using the FACT-P
- timeFrame
- Month 0 to Month 36
- description
- The FACT-P (Functional Assessment of Cancer Therapy - Prostate) is a questionnaire used to assess the health-related quality of life in men with prostate cancer.
- measure
- Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale
- timeFrame
- Month 0 to Month 36
- description
- The FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale is a questionnaire that measures an individuals level of fatigue during their usual daily activities over the past week.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male patient aged ≥ 18 years old * Able to read and sign an approved Informed Consent Form (ICF) * Diagnosed with locally advanced or metastatic prostate cancer * Patient is treatment naive for ADT or has started ADT (3 or 4 month depot injection) AND has not received more than 1 treatment of 3 or 4 month ADT OR Patient is on intermittent therapy with an ADT agent and will be restarting ADT (3 or 4 month depot injection) * ECOG (Eastern Cooperative Oncology Group) score of ≤ 2 * Willingness to track weekly physical activities with or without participating in a home based exercise program during the course of this study. The physical activities will be tracked with a weekly activity log or a NIKE+ Fuelband Exclusion Criteria: * Currently participating in a clinical study or observational study * Has a survival expectancy of \< 2 years * Has any other condition that, in the opinion of the treating physician, may affect the patient's health or outcome of the trial
References
Publications (0)
Data not yet available
No reference posted for this study.