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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772834
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Behavioral: Exercise Intervention Drug: Methylphenidate Other: Placebo Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Stretching Phase 2 Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

I. 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:

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

EXPLORATORY OBJECTIVES:

I. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023


Arm Intervention/treatment
Experimental: Group I (methylphenidate, resistance training, walking)
Patients 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.
Behavioral: Exercise Intervention
Undergo resistance training and walking

Drug: Methylphenidate
Given PO
Other Name: Daytrana

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group II (placebo, resistance training, stretching)
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.
Behavioral: Exercise Intervention
Undergo resistance training and walking

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group III (methylphenidate, stretching)
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
Drug: Methylphenidate
Given PO
Other Name: Daytrana

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Stretching
Undergo stretching

Active Comparator: Group IV (placebo, stretching)
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Stretching
Undergo stretching




Primary Outcome Measures :
  1. Level of cancer-related fatigue in all groups [ Time Frame: Up to 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in quality of life, mood, physical and cognitive measures in all groups [ Time Frame: Baseline up to 12 weeks ]
    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.


Other Outcome Measures:
  1. Synergistic effects of methylphenidate and exercise in all groups [ Time Frame: Up to 12 weeks ]
    Will measure the synergistic effects of methylphenidate and exercise in improving CRF using the AUC of the FACIT-F subscale score. The analysis will be conducted using a linear model with the AUC as the response variable and indicator variables for the exercise and methylphenidate main effects as well as a product term of these indicator variables to assess the magnitude of synergy.

  2. Change in brain activity by electroencephalography (EEG) in responders versus non-responders as measured by the FACIT-F score [ Time Frame: Baseline up to 12 weeks ]
    Responders are identified as those who report a 4 point or greater change, while non-responders report less than a 4 point change in the FACIT-F score. EEG data will be grouped according to response status. Between-group differences will be examined using univariate analysis of variance (ANOVA) with condition (responders or non-responders) as the fixed factor of interest, and the change of power from baseline to the resting state EEG at day 29 and day 84 as the dependent variable. Additional analyses will include analysis of covariance (ANCOVA) by adjusting for baseline covariates including age, stage of disease, total dose of radiotherapy, and other covariates as necessary.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772834


Contacts
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Contact: Sriram Yennu 713-792-6085 syennu@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sriram Yennu    713-792-6085      
Principal Investigator: Sriram Yennu         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sriram Yennu M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03772834    
Other Study ID Numbers: 2018-0559
NCI-2018-02527 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0559 ( Other Identifier: M D Anderson Cancer Center )
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Fatigue
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents