Multimodal Therapy for Treatment of Fatigue
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01410942
First received: August 4, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied.
Methylphenidate is a stimulant designed to increase the activity of the central nervous system.
A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
The exercise in this study is designed to help improve your physical fitness and energy levels.
Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Other: Placebo Drug: Methylphenidate Behavioral: Counseling Sessions Other: Sham Exercise Other: Standardized Exercise Intervention Program Other: Cognitive Behavioral Therapy (CBT) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Multimodal Therapy for the Treatment of Fatigue in Patients With Cancer |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Coping with Chronic Illness
Exercise and Physical Fitness
Fatigue
Prostate Cancer
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores [ Time Frame: Baseline and on Day 57 ] [ Designated as safety issue: No ]Effects of various treatments[exercise, Cognitive Behavioral Therapy (CBT), Methylphenidate] and combinations of treatments in Multimodal Therapy (MMT) in reducing cancer-related fatigue in participants with prostate cancer receiving radiotherapy (RT), as measured by change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores taken at baseline and on Day 57.
| Estimated Enrollment: | 64 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo + Sham Exercise
Placebo capsules by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
|
Other: Placebo
Capsules by mouth twice daily.
Other Name: sugar pill
Behavioral: Counseling Sessions
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
Other Name: Counseling
Other: Sham Exercise
Participants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
|
|
Experimental: Methylphenidate + Sham Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
|
Drug: Methylphenidate
Starting dose 5 mg by mouth twice daily.
Other Names:
Behavioral: Counseling Sessions
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
Other Name: Counseling
Other: Sham Exercise
Participants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
|
|
Placebo Comparator: Exercise + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Placebo capsules by mouth twice daily.
|
Other: Placebo
Capsules by mouth twice daily.
Other Name: sugar pill
Behavioral: Counseling Sessions
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
Other Name: Counseling
Other: Standardized Exercise Intervention Program
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
|
|
Placebo Comparator: Cognitive Therapy + Placebo
Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily.
|
Other: Placebo
Capsules by mouth twice daily.
Other Name: sugar pill
Other: Sham Exercise
Participants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
Other: Cognitive Behavioral Therapy (CBT)
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
|
|
Experimental: Methylphenidate + Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
|
Drug: Methylphenidate
Starting dose 5 mg by mouth twice daily.
Other Names:
Behavioral: Counseling Sessions
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
Other Name: Counseling
Other: Standardized Exercise Intervention Program
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
|
|
Experimental: Methylphenidate + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
|
Drug: Methylphenidate
Starting dose 5 mg by mouth twice daily.
Other Names:
Other: Sham Exercise
Participants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
Other: Cognitive Behavioral Therapy (CBT)
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
|
|
Placebo Comparator: Exercise + Cognitive Therapy + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily
|
Other: Placebo
Capsules by mouth twice daily.
Other Name: sugar pill
Other: Standardized Exercise Intervention Program
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
Other: Cognitive Behavioral Therapy (CBT)
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
|
|
Experimental: Methylphenidate + Exercise + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
|
Drug: Methylphenidate
Starting dose 5 mg by mouth twice daily.
Other Names:
Other: Standardized Exercise Intervention Program
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
Other: Cognitive Behavioral Therapy (CBT)
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a diagnosis of prostate cancer and are scheduled to receive radiotherapy with androgen deprivation therapy
- Rate fatigue at least 1 or higher on a scale of 0-10.
- Describe fatigue as being present every day for most of day for a minimum of 2 weeks.
- Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of </=13 at baseline.
- Be aged 18 years or older.
- Be willing to engage in follow-up telephone calls with a research nurse/coordinator.
- Be willing to participate in the exercise and in Cognitive Behavioral Therapy (CBT).
- Have telephone access to be contacted by the research nurse/coordinator.
- 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 of 0 to 2.
Exclusion Criteria:
- Have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician.
- Be currently taking MP or have taken it within the previous 10 days.
- Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week.
- Regularly used cognitive behavioral therapy in the last 6 weeks.
- Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.
- Have glaucoma.
- Have with history of severe cardiac disease (New York Heart Association functional class III or IV).
- Have tachycardia and/or uncontrolled hypertension
- Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
- History of uncontrolled hypothyroidism as evidenced by thyroid test (TSH) within the last month, hypercalcemia or hyperglycemia (within the last 15 days).
- Unable to speak and understand English
- Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410942
Contacts
| Contact: Sriram Yennurajalingam, MD | 713-792-6085 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Investigators
| Principal Investigator: | Sriram Yennurajalingam, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01410942 History of Changes |
| Other Study ID Numbers: | 2011-0389 |
| Study First Received: | August 4, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Prostate Cancer Multimodal Therapy MMT Fatigue Cognitive Behavioral Therapy CBT Radiation therapy Radiotherapy RT |
Functional Assessment of Chronic Illness Therapy - Fatigue FACIT-F Androgen deprivation therapy Methylphenidate Methylphenidate Hydrochloride Ritalin Concerta Placebo Sugar Pill |
Additional relevant MeSH terms:
|
Fatigue Prostatic Neoplasms Signs and Symptoms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013