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Diet and Exercise for Prostate Cancer (IDEA-P Trial)
N/A
Waitlist Available
Led By Brian Focht, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
IDEA-P Trial Summary
This trial is studying whether intensive diet and exercise is more effective than standard of care in improving physical function and quality of life in prostate cancer patients undergoing androgen deprivation therapy.
Who is the study for?
This trial is for men with stage IV prostate cancer starting androgen deprivation therapy (ADT). They must lead a sedentary lifestyle, have no active cardiovascular disease, and be medically cleared to exercise. Participants need consent from their oncologist and primary care physician or cardiologist.Check my eligibility
What is being tested?
The study compares intensive diet and exercise against the standard of care in improving physical function and quality of life for prostate cancer patients on ADT. It's not clear yet if this approach is better than usual treatment.See study design
What are the potential side effects?
While specific side effects are not listed, intensive dieting and exercising may cause muscle soreness, fatigue, dietary deficiencies if not properly managed, or exacerbate pre-existing health conditions.
IDEA-P Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-Efficacy
Change in body composition, assessed using the Bod Pod whole-body air displacement plethysmography system and GE Lunar dual-energy X-ray absorptiometry (iDXA) system
Change in body weight, measured using a calibrated and certified balance beam scale
+8 moreSide effects data
From 2008 Phase 3 trial • 186 Patients • NCT0000386961%
Nausea
59%
Neuro-Sensory
53%
Fatigue
49%
Anemia
32%
Vomiting
32%
Ataxia
31%
Anorexia
17%
Dyspnea
16%
Constipation
13%
Alopecia
12%
Thrombocytopenia
9%
Neutropenia
9%
Creatinine
9%
Dizziness
8%
Cough
8%
Arthralgia
7%
Vision-Blurred
6%
Depression
6%
Pain
4%
Headache
4%
Diarrhea-No Colostom
4%
Edema
4%
Infection without neutropenia
4%
Hyperglycemia
4%
Neuro-Motor
3%
Rash
3%
SGOT (AST) (serum glutamic oxaloacetic transaminase)
3%
Pain-Abdominal
3%
Pain-Chest
3%
Lymphopenia
3%
Myalgia
3%
Taste
3%
Weight loss
2%
Hemoptysis
2%
Muscle Weakness
2%
Dyspepsia
2%
Hyponatremia
2%
SGPT (ALT) (serum glutamic pyruvic transaminase)
2%
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
2%
Bilirubin
2%
Leukopenia
2%
Pain-Bone
2%
Low Consciousness
2%
Memory Loss
2%
Neuralgia
2%
Inner Ear
2%
Anxiety
2%
Confusion
1%
Dysphagia
1%
Fever-No ANC
1%
Epistaxis
1%
Hypotension
1%
Hypertension
1%
Insomnia
1%
Mouth Dryness
1%
Pulmonary
1%
Pruritis
1%
Flatulence
1%
Stomatitis
1%
Hypoalbuminemia
1%
Vision
1%
Hypoxia
1%
Smell
1%
Arrythmia
1%
Sweating
1%
Voice Change
1%
Hematemesis
1%
Prothrombin Time
1%
Adult respiratory distress syndrome (ARDS)
1%
Effusion-Pleural
1%
Pneumonitis
1%
Arrhythmia-Nodal
1%
Cardiovascular
1%
Palpitations
1%
Vision-Double
1%
Rigors
1%
Hypokalemia
1%
Musculoskeletal
1%
Learning Disorder
1%
Tremor
1%
Diarrhea-BMT
1%
Allergy
1%
Dehydration
1%
Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Carboxyamidotriazole
IDEA-P Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (diet and exercise intervention)Experimental Treatment6 Interventions
EXERCISE COMPONENT: Patients undergo 1 hour of monitored intensive exercise comprising 30 minutes of aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once weekly during weeks 7-8, and independently during weeks 7-12. All patients will complete a comprehensive exercise and quality-of-life assessment at baseline, month 2 and month 3.
BEHAVIORAL ACTIVITY COUNSELING: Patients undergo behavioral activity counseling in small group sessions over 20 minutes once weekly during months 1-2 and individualized activity counseling via telephone calls over 20 minutes every 2 weeks for 3 months. Counseling will include questionnaire administration.
BEHAVIORAL DIETARY INTERVENTION: Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
Group II: Arm II (standard of care)Active Control2 Interventions
TELEPHONE BASED COUNSELING: Patients receive standard care and educational literature describing the American Institute of Cancer Research dietary and physical activity guidelines. Patients also receive phone calls over 20 minutes every 2 weeks for 3 months focusing on routine prostate cancer self-management. After 3 months, patients have the option to undergo 2 supervised exercise training and dietary counseling sessions. All patients will complete a comprehensive exercise and quality-of-life assessment at baseline, month 2 and month 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
exercise intervention
2013
N/A
~1060
quality-of-life assessment
2012
Completed Phase 3
~2780
behavioral dietary intervention
2000
Completed Phase 1
~750
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,175 Total Patients Enrolled
10 Trials studying Prostate Cancer
2,170 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,291 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Brian Focht, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
227 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any volunteers being accepted for this experiment at the moment?
"The clinicaltrials.gov site reveals that, while this trial was initially posted on May 21st 2013 and last updated June 3rd 2022, it is not presently looking for participants. Fortunately, a plethora of other studies are actively recruiting patients to take part in their trials."
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