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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-Efficacy

Change in global and disease-specific QOL assessed using the Satisfaction with Life Scale, the Short Form (SF)-36, and the Functional Assessment of Cancer Treatment-Prostate (FACT-P)

Feasibility of delivering an intensive lifestyle exercise and dietary intervention, assessed using recruitment rates, intervention adherence, adverse events, and retention rates

Side effects data

From 2008 Phase 3 trial • 186 Patients • NCT00003869

61%

Nausea

59%

Neuro-Sensory

53%

Fatigue

49%

Anemia

32%

Vomiting

32%

Ataxia

31%

Anorexia

17%

Dyspnea

16%

Constipation

13%

Alopecia

12%

Thrombocytopenia

Neutropenia

Creatinine

Dizziness

Arthralgia

Cough

Vision-Blurred

Depression

Pain

Diarrhea-No Colostom

Headache

Edema

Infection without neutropenia

Hyperglycemia

Neuro-Motor

Rash

SGOT (AST) (serum glutamic oxaloacetic transaminase)

Pain-Abdominal

Pain-Chest

Lymphopenia

Myalgia

Taste

Weight loss

Dyspepsia

Hyponatremia

Hemoptysis

SGPT (ALT) (serum glutamic pyruvic transaminase)

Muscle Weakness

Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)

Bilirubin

Leukopenia

Pain-Bone

Low Consciousness

Memory Loss

Neuralgia

Inner Ear

Anxiety

Confusion

Stomatitis

Pruritis

Mouth Dryness

Smell

Hypoxia

Dysphagia

Hypoalbuminemia

Insomnia

Voice Change

Vision

Hypertension

Arrythmia

Sweating

Epistaxis

Flatulence

Fever-No ANC

Pulmonary

Hypotension

Hematemesis

Prothrombin Time

Adult respiratory distress syndrome (ARDS)

Effusion-Pleural

Pneumonitis

Arrhythmia-Nodal

Cardiovascular

Palpitations

Vision-Double

Rigors

Hypokalemia

Musculoskeletal

Learning Disorder

Tremor

Diarrhea-BMT

Allergy

Dehydration

Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Carboxyamidotriazole

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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