Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01410942 |
| Other study ID # |
2011-0389 |
| Secondary ID |
RSG-11-170-01-PC |
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2012 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
If you are found eligible and agree to take part in the study:
- You will complete a baseline exercise assessment which will last about 30-45 minutes and
include the following:
- A sit-to-stand test. You will sit in chair with your arms across your chest. Then you
will be timed as you stand and sit down 5 times as quickly as possible.
- A hand-grip strength test. You will grip a device with each hand as hard as you can.
- A 6-minute walk test. You will be timed while you walk on a 100-foot loop. You will walk
50 feet and then turn and walk back to the beginning. You will do this at a walking
speed that feels comfortable and for as many times as you can in 6 minutes.
- You will be given a belt (accelerometer) that you are required to wear for the first
week of treatment. The accelerometer measures your physical activity.
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 (+/- 10 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 (+/- 10 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 175 patients will take part in this study. All will be enrolled at MD Anderson.
