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NCT03525873 · ClinicalTrials.gov registry record · Phase 3
A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy
A Phase 3 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
- 1
- Study location
NCT03525873: Active Phase 3 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT03525873 is a Phase 3 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 212 participants, above the 163-participant average among 16 other Advanced Malignant Neoplasm trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03525873, a Phase 3 study of Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase III trial studies how well methylphenidate and physical activity works in reducing cancer-related fatigue in patients who are receiving anti-PD1 immunotherapy for cancer that has spread to other places in the body. Central nervous systems stimulants, such as methylphenidate, may help to improve cognitive function. Physical activity uses techniques, such as aerobic and resistance exercises, which may help to improve quality of life. Giving methylphenidate and physical activity may help in reducing cancer-related fatigue in patients with metastatic cancer who receive anti-PD1 immunotherapy.
Primary Outcome
Effects of MP to be compared to placebo plus physical activity results. To be as measured by changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) sub-scale scores. A t test will be used to evaluate the difference between groups unless the data appear to be non-normally distributed, in which case a Wilcoxon rank-sum test will be used to evaluate the difference between groups.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Methylphenidate
- OTHER Physical Activity
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2018-08-02 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03525873 still lists
NCT03525873 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, above the 163-participant average among 16 other Advanced Malignant Neoplasm trials with a reported enrollment target (30% higher).
The record links to 3 conditions, with Advanced Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03525873 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03525873 about?
NCT03525873 is a clinical study titled "A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy". This phase III trial studies how well methylphenidate and physical activity works in reducing cancer-related fatigue in patients who are receiving anti-PD1 immunotherapy for cancer that has spread to other places in the body. Central nervous systems stimulants, such as methylphenidate, may help to i...
What is the current status of trial NCT03525873?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2018-08-02. Estimated completion is 2026-12-31.
What conditions does trial NCT03525873 study?
This clinical trial studies the following conditions: Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm.
What interventions are being tested in trial NCT03525873?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Methylphenidate (DRUG), Physical Activity (OTHER).
Who is sponsoring clinical trial NCT03525873?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03525873 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
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Where NCT03525873's enrollment target sits among peer trials
212 5th of 16 higher than 12 of 16 other Advanced Malignant Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Neoplasm 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.
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