Back to results

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

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

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

NCT ID

NCT03772834

First Posted

December 7, 2018

Last Updated

September 21, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

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

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

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

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

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

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

We'll reach out to this number within 24 hrs