Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

February 8, 2012

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Prostate Cancer
Interventions
OTHER

Placebo

Capsules by mouth twice daily.

DRUG

Methylphenidate

Starting dose 5 mg by mouth twice daily.

BEHAVIORAL

Counseling Sessions

8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.

OTHER

Sham Exercise

Participants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

OTHER

Standardized Exercise Intervention Program

Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.

OTHER

Cognitive Behavioral Therapy (CBT)

8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

American Cancer Society, Inc.

OTHER

lead

M.D. Anderson Cancer Center

OTHER