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Multimodal Therapy for the Treatment of Fatigue in Patients With Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Multimodal Therapy for the Treatment of Fatigue in Patients With Cancer


Study Groups:

You will be randomly assigned (as in the roll of dice) to 1 of 8 study groups. You will
have an equal chance of being assigned to any group. You will have a 50% chance of
receiving the placebo.

The exercises and skills learned during counseling will be different for each study group.
The study staff will talk to you about your assigned exercises and skills. You will be
assigned to 1 of 2 types of exercise groups. One group will do resistance exercises and
walking, and the other group will do stretching.

You be assigned to 1 of 2 types of counselling groups. One group will receive education on
relaxation and symptoms. The other group will receive standard supportive counseling.

Neither you nor the medical study staff will know which group you are in. Only the study
staff who will work with you for the exercise and counseling will know which group you are
in. If needed for your safety, the medical staff will be able to find out which group you
are in.

Study Drug/Placebo Administration:

You will take the methylphenidate/placebo capsules by mouth with water, 2 times each day.
You must take both doses before 3 PM and wait at least 2 hours between doses.

Study Visits:

For all study visits/calls, you will be asked about any drugs you may be taking or any side
effects that you may be having. At home during the study, you will continue practicing
exercises from the exercise sessions and skills from the counseling sessions.

On Day 1, if not done at Screening:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs.

- You will complete 5 questionnaires, which should last about 30 minutes. The
questionnaires ask about:

- Your emotional and physical well being

- Your level of fatigue

- Any anxiety and/or depression you may be having

- Any symptoms you may be having

On Day 8 (+/- 3 days):

- You will meet with a counselor. You will be asked to discuss your thoughts and
feelings on different topics related to your well-being. The counseling session will
last about 45 minutes.

- You will meet with the exercise trainer. The exercise trainer will teach you exercises
and give you written instructions for how to do them at home. The exercise meeting
will last about 30-45 minutes.

- You will be asked to complete a questionnaire that asks about any symptoms and/or side
effects that you may be having. This should take about 10 minutes.

On Days 15 and 29 (+/- 3 days):

- You will exercise and then be asked how the exercises are going either in person or
later over the phone. This should last about 30 minutes.

- You will have a counseling session with a counselor over the phone. This should last
about 45 minutes.

- You will complete the 5 questionnaires.

On Days 22 and 36 (+/- 3 days) the exercise trainer and the counselor will call. These
calls should last between 30-45 minutes.

On Day 43 (+/- 3 days) the exercise trainer and the counselor will call. These calls should
last between 30-45 minutes.

-You will complete a questionnaire that asks about any symptoms and/or side effects you may
be having. This should take about 10 minutes.

On Day 50 (+/- 3 days) the exercise trainer and the counselor will call if you have any
uncompleted sessions. These calls should last between 30-45 minutes.

-You will be given an accelerometer that you are required to wear for the last week of
treatment.

On Day 57 (+/- 5 days) you will return to the clinic::

- You will have a physical exam, including measurement of your vital signs.

- You will complete a sit-to-stand test.

- You will complete a hand-grip strength test.

- You will complete a 6-minute walk test.

- You will complete the 5 questionnaires.

Length of Study Participation:

You may continue taking the study drug/placebo for up to 57 days (+/- 5 days). You will no
longer be able to take the study drug/placebo if the disease gets worse, if intolerable side
effects occur, if you are unable to follow study directions, or if you cannot complete
enough of the treatment combination as planned.

Your participation on the study will be over after you have completed the follow-up visit.

Follow-Up Visit:

About 3 months after your last dose of study drug/placebo, you will return to the clinic for
a follow-up visit:

- You will be asked about any side effects you may have had.

- You will have a physical exam, including measurement of your vital signs.

- Your performance status will be recorded.

- You will complete a sit-to-stand test.

- You will complete hand-grip strength tests.

- You will complete a 6-minute walk test.

- You will be asked to complete the 5 questionnaires.

This is an investigational study. Methylphenidate tablets are FDA approved and
commercially available for the treatment of attention deficit disorder (ADD). The
methylphenidate capsules made from the methylphenidate tablets especially for this study are
not approved by the FDA. The combination of methylphenidate, exercise, and counseling is
considered investigational.

Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.


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
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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores

Outcome Description:

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.

Outcome Time Frame:

Baseline and on Day 57

Safety Issue:

No

Principal Investigator

Sriram Yennurajalingam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0389

NCT ID:

NCT01410942

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • 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
  • Fatigue
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030