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NCT01410942 · ClinicalTrials.gov registry record · Phase 2
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
A Phase 2 study of Prostate Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
- 1
- Study location
NCT01410942: Active Phase 2 study of Prostate Cancer, sponsored by M.D. Anderson Cancer Center.
NCT01410942 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 175 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410942, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied. Methylphenidate is a stimulant designed to increase the activity of the central nervous system. A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. The exercise in this study is designed to help improve your physical fitness and energy levels. Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.
Primary Outcome
Effects of various treatments\[exercise, Cognitive Behavioral Therapy (CBT), Methylphenidate\] and combinations of treatments in Multimodal Therapy (MMT) in reducing cancer-related fatigue in participants with prostate cancer receiving radiotherapy (RT), as measured by change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores taken at baseline and on Day 57.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Methylphenidate
- BEHAVIORAL Counseling Sessions
- OTHER Sham Exercise
- OTHER Standardized Exercise Intervention Program
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2012-02-08 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What the registry record for NCT01410942 still lists
NCT01410942 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01410942 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01410942 about?
NCT01410942 is a clinical study titled "Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy". The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied. Methylphenida...
What is the current status of trial NCT01410942?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2012-02-08. Estimated completion is 2026-09-30.
What conditions does trial NCT01410942 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01410942?
The interventions under investigation include: Placebo (OTHER), Methylphenidate (DRUG), Counseling Sessions (BEHAVIORAL), Sham Exercise (OTHER), Standardized Exercise Intervention Program (OTHER).
Who is sponsoring clinical trial NCT01410942?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01410942 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01410942's enrollment target sits among peer trials
175 245th of 735 higher than 490 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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