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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and on day 57

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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I am 18 years old or older.

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

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,280 Total Patients Enrolled

11 Trials studying Prostate Cancer

1,705 Patients Enrolled for Prostate Cancer

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,627 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,565 Patients Enrolled for Prostate Cancer

Sriram Yennurajalingam, MDPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

448 Total Patients Enrolled

Media Library

Methylphenidate (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT01410942 — Phase 2

Prostate Cancer Research Study Groups: Methylphenidate + Cognitive Therapy, Cognitive Therapy + Placebo, Methylphenidate + Exercise, Placebo + Sham Exercise, Methylphenidate + Sham Exercise, Exercise + Placebo, Exercise + Cognitive Therapy + Placebo, Methylphenidate + Exercise + Cognitive Therapy

Prostate Cancer Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT01410942 — Phase 2

Methylphenidate (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01410942 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research subjects are enrolled in this experiment?

"No, this particular trial is no longer looking for patients. Although, it should be noted that the clinical trial was originally posted on February 1st 2012 and was most recently updated on June 29th 2022. If you are seeking other studies, there are presently 1577 studies actively recruiting participants with prostate cancer and 30 studies for Standardized Exercise Intervention Program actively admitting participants."

Answered by AI

Are there other research projects that focus on Standardized Exercise Intervention Program?

"As of now, there are 30 ongoing clinical trials investigating the effects of Standardized Exercise Intervention Program. 2 out of these 30 are large-scale Phase 3 trials. Although many of the research projects related to this topic are based in Lexington, Kentucky, 43 different locations across the world are running similar studies."

Answered by AI

Can new people still join this trial?

"This clinical trial, which was first posted on February 1st 2012 and last updated on June 29th 2022, is not currently recruiting participants. However, there are 1607 other studies that are actively recruiting patients at this time."

Answered by AI

Does the FDA recognize the Standardized Exercise Intervention Program as an effective treatment?

"Standardized Exercise Intervention Program scored a 2 in terms of safety. This is due to the fact that, while there is evidence backing its safety, Phase 2 trials have yet to provide data regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2012. "Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01410942.

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