Multimodal Therapy for Treatment of Fatigue

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
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: April 23, 2014
Last verified: April 2014
  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:


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: 175
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:
  • Methyphenidate Hydrochloride
  • Ritalin
  • Concerta
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:
  • Methyphenidate Hydrochloride
  • Ritalin
  • Concerta
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:
  • Methyphenidate Hydrochloride
  • Ritalin
  • Concerta
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:
  • Methyphenidate Hydrochloride
  • Ritalin
  • Concerta
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:

  1. Have a diagnosis of prostate cancer and are scheduled to receive radiotherapy with androgen deprivation therapy
  2. Rate fatigue at least 1 or higher on a scale of 0-10.
  3. Describe fatigue as being present every day for most of day for a minimum of 2 weeks.
  4. Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of </=13 at baseline.
  5. Be aged 18 years or older.
  6. Be willing to engage in follow-up telephone calls with a research nurse/coordinator.
  7. Be willing to participate in the exercise and in Cognitive Behavioral Therapy (CBT).
  8. Have telephone access to be contacted by the research nurse/coordinator.
  9. Have a hemoglobin level of >/=10 g/dL within 2 weeks of enrollment.
  10. Be able to understand the description of the study and give written informed consent.
  11. Have a Zubrod performance status of 0 to 2.

Exclusion Criteria:

  1. 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.
  2. Be currently taking MP or have taken it within the previous 10 days.
  3. Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week.
  4. Regularly used cognitive behavioral therapy in the last 6 weeks.
  5. Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
  6. Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.
  7. Have glaucoma.
  8. Have with history of severe cardiac disease (New York Heart Association functional class III or IV).
  9. Have tachycardia and/or uncontrolled hypertension
  10. Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
  11. History of uncontrolled hypothyroidism as evidenced by thyroid test (TSH) within the last month, hypercalcemia or hyperglycemia (within the last 15 days).
  12. Unable to speak and understand English
  13. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, RSG-11-170-01-PCSM, NCI-2011-02764
Study First Received: August 4, 2011
Last Updated: April 23, 2014
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
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014