← Back to Search

Stimulant

Multimodal Therapy for Fatigue in Prostate Cancer

Phase 2

Waitlist Available

Led By Sriram Yennurajalingam, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Describe fatigue as being present every day for most of the day for a minimum of 2 weeks

Be aged 18 years or older

Must not have

Have glaucoma

Regularly used cognitive behavioral therapy in the last 6 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and on day 57

Summary

This trial is testing if a combination of exercise, supportive counseling, and methylphenidate/placebo can help improve fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied.

Who is the study for?

This trial is for adults with prostate cancer experiencing daily fatigue, who are about to start radiotherapy with androgen deprivation therapy. They must not be heavily active or using certain therapies or medications that could interfere with the study, have a reasonable level of physical function (Zubrod status 0-2), and no severe cognitive issues or cardiac disease.

What is being tested?

The study tests how exercise, counseling, and methylphenidate (a stimulant) versus placebo affect fatigue in prostate cancer patients undergoing specific treatments. It explores different combinations of these interventions to see which might improve energy levels and overall well-being.

What are the potential side effects?

Methylphenidate may cause increased heart rate, high blood pressure, anxiety, trouble sleeping, appetite loss; while exercise can pose risks if there's an underlying heart condition. Counseling typically has minimal side effects but can sometimes bring up uncomfortable emotions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have felt extremely tired every day for at least two weeks.

Select...

I am 18 years old or older.

Select...

I feel tired at a level of 1 or more on a scale up to 10.

Select...

I have prostate cancer and will get radiotherapy with hormone therapy.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have glaucoma.

Select...

I have been using cognitive behavioral therapy regularly for the last 6 weeks.

Select...

I have severe heart disease.

Select...

I need medication for depression or blood pressure.

Select...

I am currently taking medication for blood clots, seizures, pain/inflammation, or depression.

Select...

I have a fast heart rate or high blood pressure that isn't controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and on day 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and on day 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and on day 57 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 Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Methylphenidate + Sham ExerciseExperimental Treatment3 Interventions

Methylphenidate starting dose 5 mg by mouth twice daily. Participants in 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.

Group II: Methylphenidate + Exercise + Cognitive TherapyExperimental Treatment3 Interventions

Methylphenidate starting dose 5 mg by mouth twice daily. 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. Cognitive Therapy - 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.

Group III: Methylphenidate + ExerciseExperimental Treatment3 Interventions

Group IV: Methylphenidate + Cognitive TherapyExperimental Treatment3 Interventions

Methylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 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.

Group V: Cognitive Therapy + PlaceboPlacebo Group3 Interventions

Cognitive Therapy - 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. Placebo capsules by mouth twice daily.

Group VI: Placebo + Sham ExercisePlacebo Group3 Interventions

Placebo capsules by mouth twice daily. Participants in 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.

Group VII: Exercise + PlaceboPlacebo Group3 Interventions

Group VIII: Exercise + Cognitive Therapy + PlaceboPlacebo Group3 Interventions

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. Cognitive Therapy - 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. Placebo capsules by mouth twice daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

Counseling Sessions

2006

Completed Phase 2

~460