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

Primary Purpose

Prostate Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Methylphenidate
Placebo
Quality-of-Life Assessment
Questionnaire Administration
Stretching
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group I (methylphenidate, resistance training, walking)

Group II (placebo, resistance training, stretching)

Group III (methylphenidate, stretching)

Group IV (placebo, stretching)

Arm Description

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.

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 7, 2018
Last Updated
September 21, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03772834
Brief Title
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Official Title
A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (methylphenidate, resistance training, walking)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (placebo, resistance training, stretching)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group III (methylphenidate, stretching)
Arm Type
Active Comparator
Arm Description
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
Arm Title
Group IV (placebo, stretching)
Arm Type
Active Comparator
Arm Description
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo resistance training and walking
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Daytrana
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
Undergo stretching
Primary Outcome Measure Information:
Title
Level of cancer-related fatigue in all groups
Description
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.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life, mood, physical and cognitive measures in all groups
Description
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.
Time Frame
Baseline up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Synergistic effects of methylphenidate and exercise in all groups
Description
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.
Time Frame
Up to 12 weeks
Title
Change in brain activity by electroencephalography (EEG) in responders versus non-responders as measured by the FACIT-F score
Description
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.
Time Frame
Baseline up to 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sriram Yennu
Phone
713-792-6085
Email
syennu@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Yennu
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sriram Yennu
Phone
713-792-6085
First Name & Middle Initial & Last Name & Degree
Sriram Yennu

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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