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Methylphenidate + Exercise for Cancer-Related Fatigue

Phase 3
Waitlist Available
Led By Sriram Yennu
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 2, 6, and 10
Awards & highlights

Study Summary

This trial is testing if a combination of methylphenidate and physical activity can help to reduce cancer-related fatigue in patients receiving anti-PD1 immunotherapy.

Who is the study for?
This trial is for adults with metastatic or recurrent cancer who have fatigue from recent anti-PD1 immunotherapy. They must be able to communicate in English, consent to the study, and participate in follow-up calls. Excluded are those with glaucoma, certain medication use (anticoagulants, anticonvulsants), cognitive failure, specific heart diseases, or severe allergies to trial medications.Check my eligibility
What is being tested?
The study tests if methylphenidate combined with physical activity reduces fatigue in patients undergoing anti-PD1 immunotherapy for advanced cancer. It compares the effects of a stimulant drug and exercise routines against usual care without these interventions.See study design
What are the potential side effects?
Methylphenidate may cause side effects like increased heart rate, high blood pressure, insomnia, nervousness and potential for addiction. Physical activity generally has benefits but can sometimes lead to muscle soreness or injury if not done properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 2, 6, and 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 2, 6, and 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of the effects of methylphenidate (MP) plus physical activity in reducing cancer-related fatigue (CRF)
Secondary outcome measures
Assessment of MP effects on anxiety, depressed mood, and cancer symptoms by questionnaires
Assessment of MP effects on physical activity
Other outcome measures
Assessment of MP effects on levels of serum IL-1b, IL-1 RA, IL-6, TNF-a, IL-8,IL-10, and MCP1

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARM I (methylphenidate, physical activity)Experimental Treatment5 Interventions
Patients receive methylphenidate PO BID for up to 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete physical activity consisting of walking and resistance exercise over 25-40 minutes QD 4 days a week. After 2 weeks, patients may continue methylphenidate at the discretion of the treating physician for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Group II: ARM II (placebo, physical activity)Placebo Group5 Interventions
Patients receive a matched placebo PO BID and complete physical activity as in Arm I. Treatment continues for up to 2 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
2014
Completed Phase 4
~431850

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,127 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,063 Total Patients Enrolled
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,345 Total Patients Enrolled

Media Library

Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT03525873 — Phase 3
Cancer Research Study Groups: ARM I (methylphenidate, physical activity), ARM II (placebo, physical activity)
Cancer Clinical Trial 2023: Physical Activity Highlights & Side Effects. Trial Name: NCT03525873 — Phase 3
Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT03525873 — Phase 3

Frequently Asked Questions

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

How many guinea pigs are helping out with this experiment?

"This study is not recruiting at the moment. However, it was first posted on August 2nd, 2018 and last updated on November 9th, 2021. If you are interested in other trials, there are presently 3396 studies actively searching for participants with metastatic malignant neoplasm and 30 trials for Physical Activity actively admitting participants."

Answered by AI

Has research been conducted on the effects of physical activity in the past?

"At this moment, there are a total of 30 ongoing studies related to the effects of physical activity. Out of these 30 studies, 2 are in Phase 3. Most of the research locations for physical activity are situated in Lexington, Kentucky; however, there are 43 different locations running clinical trials."

Answered by AI

What are the risks associated with physical activity for patients?

"We believe that physical activity is safe and has a positive effect on health, so we give it a score of 3."

Answered by AI
~25 spots leftby Dec 2024