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Prostate CarcinomaPhase 2/3NCT03772834

Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer

A Phase 2/3 study testing Exercise Intervention, Methylphenidate and Quality-of-Life Assessment in people with Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II/III trial studies how well methylphenidate and exercise work in reducing cancer-related fatigue in patients with prostate cancer. Methylphenidate is a type of central nervous system stimulant that can improve cognitive ability, mainly in memory and cognitive function. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Exercise Intervention, Methylphenidate and Quality-of-Life Assessment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited States
Study dates
25 Mar 2019to 30 Nov 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of prostate cancer and be scheduled to receive radiotherapy with concurrent androgen deprivation therapy, and presence of fatigue with severity of 1/10, on a 0-10 scale for at least 2 weeks
  • Patient not regularly engaging in moderate aerobic exercise for >90 minutes/week and/or vigorous aerobic exercise for >30 minutes/week, and/ or strength training for >/= 1 day/week
  • Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of </=13 at baseline
  • Be aged 18 years or older
  • Be willing to engage in follow-up telephone calls with a research staff
  • Be willing to participate in the exercise programs
Show all 11Show fewer
  • Have telephone access so they can be contacted by the research staff
  • Have a hemoglobin level of >/= 10 g/dL within 2 weeks of enrollment
  • Be able to understand the description of the study and give written informed consent
  • Have a Zubrod performance status score of 0 to 2
  • Seen at an outpatient clinic at MD Anderson Cancer Center, its Houston Area Locations (HALs) or Smith Radiation Oncology Clinic (HHS)

Who cannot join

  • Have a major contraindication to MethylphenidateMP) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), or conditions making adherence difficult as determined by the attending physician
  • Be currently taking MP, or have taken it within the previous 10 days
  • Be unable to complete the baseline assessment forms (e.g., due to language or sensory barriers) or to understand the recommendations for participation in the study
  • Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
  • Have glaucoma
  • Have severe cardiac disease (New York Heart Association functional class III or IV)
  • Have tachycardia and/or uncontrolled hypertension
  • Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01

This phase II/III trial studies how well methylphenidate and exercise work in reducing cancer-related fatigue in patients with prostate cancer. Methylphenidate is a type of central nervous system stimulant that can improve cognitive ability, mainly in memory and cognitive function. Exercise can improve mood and the physical aspects of cancer-related fatigue. Giving methylphenidate in combination with exercise may work better in reducing cancer-related fatigue in patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if the combination of exercise (EX) plus methylphenidate (MP) is superior to exercise plus placebo in the treatment of cancer-related fatigue (CRF) in patients with prostate cancer scheduled to receive radiotherapy with androgen deprivation therapy for 12 weeks.

SECONDARY OBJECTIVE:

  1. To determine the effects of combined exercise plus methylphenidate on quality-of-life, mood, physical, and cognitive measures.

EXPLORATORY OBJECTIVES:

  1. To identify potential synergistic effects of exercise and methylphenidate in improvement of CRF.

II. To explore changes in brain activity by electroencephalography (EEG) in responders (with 4 point or greater change in Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F] scores) versus (vs) non-responders to the intervention.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP I: Patients receive methylphenidate orally (PO) twice daily (BID) and undergo exercise program consisting of resistance training twice weekly (BIW) and walking 15- 40 minutes a day 4 days a week for 12 weeks.

GROUP II: Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.

GROUP III: Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.

GROUP IV: Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.

After completion of study treatment, patients are followed up at 3 months.

Being tested
Exercise Intervention, Methylphenidate, Placebo, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionBehavioural

    Undergo resistance training and walking

  • MethylphenidateDrug

    Also called Daytrana

    Given PO

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • StretchingOther

    Undergo stretching

Study groups in NCT03772834
Study groupRoleWhat they receive
Group I (methylphenidate, resistance training, walking)ExperimentalPatients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
Receives: Behavioral: Exercise Intervention; Drug: Methylphenidate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (placebo, resistance training, stretching)Active comparatorPatients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
Receives: Behavioral: Exercise Intervention; Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group III (methylphenidate, stretching)Active comparatorPatients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
Receives: Drug: Methylphenidate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Stretching
Group IV (placebo, stretching)Active comparatorPatients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
Receives: Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of cancer-related fatigue in all groups

    Will measure cancer-related fatigue (CRF) using the area under the curve (AUC) of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale score. The intervention exposure will be operationalized as proportion of the total minutes of prescribed exercise intervention the study patient was actually able to participate, or the proportion of prescribed study medication the study patient was able to actually take.

    Measured: Up to 12 weeks

Secondary outcomes (1)

  1. Change in quality of life, mood, physical and cognitive measures in all groups

    Will use a mixed-effects model to compare changes in Functional Assessment of Cancer Therapy - General (FACT-G), Pittsburgh Sleep Quality Index (PSQI), Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF), Hospital Anxiety and Depression Scale (HADS), usual gait speed, hand grip strength (HGS), 30 second chair stand test (30s-CST), actigraphy, VO2 max, and C-reactive protein scores over time between the four treatment groups. For the mixed effects model, we will estimate the slopes for the changes in scores over time for each group and test the difference in these slopes.

    Measured: Baseline up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2018
  2. Study start25 Mar 2019
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03772834
Sponsor's protocol ID
2018-0559
Other IDs
NCI-2018-02527, 2018-0559
Status last verified
Nov 2026
First submitted
7 Dec 2018
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Exercise Intervention, Methylphenidate and Quality-of-Life Assessment in people with Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of cancer-related fatigue in all groups (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03772834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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