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ACTIVE NOT RECRUITING Phase 3

A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy

NCT03525873 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 212 participants
Start Date 2018-08-02
Est. Completion 2026-12-31
Phase Phase 3

Sponsor

M.D. Anderson Cancer Center

2,992 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03525873

The ClinicalTrials.gov registry entry for NCT03525873 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,992 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03525873 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03525873?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,992 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial