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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores
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.
Baseline and on Day 57
No
Sriram Yennurajalingam, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2011-0389
NCT01410942
February 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |