Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-14 @ 5:52 AM
Study NCT ID:
NCT03772834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2018-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Synergistic effects of methylphenidate and exercise in all groups', 'timeFrame': 'Up to 12 weeks', '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.'}, {'measure': 'Change in brain activity by electroencephalography (EEG) in responders versus non-responders as measured by the FACIT-F score', 'timeFrame': 'Baseline up to 12 weeks', '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.'}], 'primaryOutcomes': [{'measure': 'Level of cancer-related fatigue in all groups', 'timeFrame': 'Up to 12 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life, mood, physical and cognitive measures in all groups', 'timeFrame': 'Baseline up to 12 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. 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.\n\nSECONDARY OBJECTIVE:\n\nI. To determine the effects of combined exercise plus methylphenidate on quality-of-life, mood, physical, and cognitive measures.\n\nEXPLORATORY OBJECTIVES:\n\nI. To identify potential synergistic effects of exercise and methylphenidate in improvement of CRF.\n\nII. 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.\n\nOUTLINE: Patients are randomized to 1 of 4 groups.\n\nGROUP 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.\n\nGROUP 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.\n\nGROUP III: Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.\n\nGROUP IV: Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.\n\nAfter completion of study treatment, patients are followed up at 3 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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\n* Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of \\</=13 at baseline\n* Be aged 18 years or older\n* Be willing to engage in follow-up telephone calls with a research staff\n* Be willing to participate in the exercise programs\n* Have telephone access so they can be contacted by the research staff\n* Have a hemoglobin level of \\>/= 10 g/dL within 2 weeks of enrollment\n* Be able to understand the description of the study and give written informed consent\n* Have a Zubrod performance status score of 0 to 2\n* Seen at an outpatient clinic at MD Anderson Cancer Center, its Houston Area Locations (HALs) or Smith Radiation Oncology Clinic (HHS)\n\nExclusion Criteria:\n\n* 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\n* Be currently taking MP, or have taken it within the previous 10 days\n* 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\n* Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine\n* Have glaucoma\n* Have severe cardiac disease (New York Heart Association functional class III or IV)\n* Have tachycardia and/or uncontrolled hypertension\n* Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).'}, 'identificationModule': {'nctId': 'NCT03772834', 'briefTitle': 'Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01', 'orgStudyIdInfo': {'id': '2018-0559'}, 'secondaryIdInfos': [{'id': 'NCI-2018-02527', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-0559', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (methylphenidate, resistance training, walking)', '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.', 'interventionNames': ['Behavioral: Exercise Intervention', 'Drug: Methylphenidate', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (placebo, resistance training, stretching)', '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.', 'interventionNames': ['Behavioral: Exercise Intervention', 'Other: Placebo', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III (methylphenidate, stretching)', 'description': 'Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.', 'interventionNames': ['Drug: Methylphenidate', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Other: Stretching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group IV (placebo, stretching)', 'description': 'Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.', 'interventionNames': ['Other: Placebo', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Other: Stretching']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Undergo resistance training and walking', 'armGroupLabels': ['Group I (methylphenidate, resistance training, walking)', 'Group II (placebo, resistance training, stretching)']}, {'name': 'Methylphenidate', 'type': 'DRUG', 'otherNames': ['Daytrana'], 'description': 'Given PO', 'armGroupLabels': ['Group I (methylphenidate, resistance training, walking)', 'Group III (methylphenidate, stretching)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy'], 'description': 'Given PO', 'armGroupLabels': ['Group II (placebo, resistance training, stretching)', 'Group IV (placebo, stretching)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (methylphenidate, resistance training, walking)', 'Group II (placebo, resistance training, stretching)', 'Group III (methylphenidate, stretching)', 'Group IV (placebo, stretching)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (methylphenidate, resistance training, walking)', 'Group II (placebo, resistance training, stretching)', 'Group III (methylphenidate, stretching)', 'Group IV (placebo, stretching)']}, {'name': 'Stretching', 'type': 'OTHER', 'description': 'Undergo stretching', 'armGroupLabels': ['Group III (methylphenidate, stretching)', 'Group IV (placebo, stretching)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sriram Yennu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}