Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01906008
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2013-07-18
Brief Title:
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Randomized Placebo-Controlled Study of Minocycline for Reducing Symptom Burden in Patients With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if minocycline can reduce numbness pain andor loss of motor function in patients with colorectal cancer In this study minocycline will be compared to a placebo
The study doctor can explain how the study drug is designed to work
A placebo is not a drug It looks like the study drug but it is not designed to treat any disease or illness It is designed to be compared with a study drug to learn if the study drug has any real effect
The study doctor can explain how the study drug is designed to work
A placebo is not a drug It looks like the study drug but it is not designed to treat any disease or illness It is designed to be compared with a study drug to learn if the study drug has any real effect
Detailed Description:
Nearly 40 of patients with colorectal cancer who receive oxaliplatin-based chemotherapy experience neuropathy nerve damage that can include numbness pain andor loss of motor function Sometimes this nerve damage is serious enough that the chemotherapy dose has to be lowered or stopped completely Researchers want to find out if taking minocycline can lower the side effects caused by chemotherapy given to treat colorectal cancer
Study Groups
If you agree to take part in this study you will be randomly assigned as in the flip of a coin to 1 of 2 groups You will have an equal chance of being in either group
If you are in Group 1 you will take a placebo
If you are in Group 2 you will take minocycline
Neither you nor the study staff will know if you are receiving the study drug or the placebo However if needed for your safety the study staff will be able to find out what you are receiving
Study Drug Administration
Starting on Day 1 of Cycle 1 of chemotherapy you will start taking the study drugplacebo capsule by mouth twice a day every day
You should take the study drugplacebo with a full glass 8 ounces of water You may take it with or without food but if it causes an upset stomach you should take it with food
You should not lie down for at least 30 minutes after taking the study drugplacebo to reduce the risk of side effects
Study Visits
Before you start taking the study drugplacebo
You will complete 4 questionnaires about pain and other symptoms and your quality of life You will also complete a questionnaire about your tobacco history It should take about 15-25 minutes to complete all questionnaires
You may complete a sensory test For this test researchers will try to find out how sensitive you are to touching things such as small bumps on a board This test will take about 10 minutes to complete
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation Markers of inflammation are found in the blood and may be related to your symptoms
1 time each week
You will complete a questionnaire in the clinic or by telephone about any symptoms you may be having and how they may be affecting your daily activities The questionnaire should take about 3-5 minutes to complete each time
At each chemotherapy cycle
You will fill out 2 questionnaires in the clinic or by telephone about pain and other symptoms It should take about 10-15 minutes to complete the questionnaires
The study staff will make a count of the number of pills that you took so far If you are coming to the MD Anderson or Harris Health clinic bring the study drugplacebo container along with any remaining drugplacebo
At about 2 months
If you return to the MD Anderson or Harris Health clinic for this visit the following additional procedures will be performed
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation
You may complete a sensory test This test will take about 10 minutes to complete
End-of-Treatment Visit at about 4 months
You will fill out the 4 questionnaires in the clinic or by telephone about your symptoms It should take about 15-20 minutes to complete all of the questionnaires
The study staff will make a count of the number of pills that you took so far
If you return to the MD Anderson or Harris Health clinic for this visit
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation
You may complete a sensory test This test will take about 10 minutes to complete
You must bring the study drugplacebo container along with any remaining drugplacebo
Length of Study
You may continue taking the study drugplacebo for up to 4 months if there are no treatment delays You will no longer be able to take the study drug if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions
Your participation in the study will be over at the End-of-Study visit
End-of-Study Visit
At about 6 months the following tests and procedures will be performed
You will fill out 4 questionnaires in the clinic or by telephone about pain and other symptoms and your quality of life You will also complete a questionnaire about your tobacco history It should take about 15-25 minutes to complete all of the questionnaires
If you return to the MD Anderson or Harris Health clinic for this visit
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation
You may complete a sensory test This test will take about 10 minutes to complete
This is an investigational study Minocycline is FDA approved and commercially available for the treatment of bacterial infection Its use in this study is investigational
Up to 166 participants will be enrolled in this study Up to 83 will be enrolled at the Harris Health System
Study Groups
If you agree to take part in this study you will be randomly assigned as in the flip of a coin to 1 of 2 groups You will have an equal chance of being in either group
If you are in Group 1 you will take a placebo
If you are in Group 2 you will take minocycline
Neither you nor the study staff will know if you are receiving the study drug or the placebo However if needed for your safety the study staff will be able to find out what you are receiving
Study Drug Administration
Starting on Day 1 of Cycle 1 of chemotherapy you will start taking the study drugplacebo capsule by mouth twice a day every day
You should take the study drugplacebo with a full glass 8 ounces of water You may take it with or without food but if it causes an upset stomach you should take it with food
You should not lie down for at least 30 minutes after taking the study drugplacebo to reduce the risk of side effects
Study Visits
Before you start taking the study drugplacebo
You will complete 4 questionnaires about pain and other symptoms and your quality of life You will also complete a questionnaire about your tobacco history It should take about 15-25 minutes to complete all questionnaires
You may complete a sensory test For this test researchers will try to find out how sensitive you are to touching things such as small bumps on a board This test will take about 10 minutes to complete
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation Markers of inflammation are found in the blood and may be related to your symptoms
1 time each week
You will complete a questionnaire in the clinic or by telephone about any symptoms you may be having and how they may be affecting your daily activities The questionnaire should take about 3-5 minutes to complete each time
At each chemotherapy cycle
You will fill out 2 questionnaires in the clinic or by telephone about pain and other symptoms It should take about 10-15 minutes to complete the questionnaires
The study staff will make a count of the number of pills that you took so far If you are coming to the MD Anderson or Harris Health clinic bring the study drugplacebo container along with any remaining drugplacebo
At about 2 months
If you return to the MD Anderson or Harris Health clinic for this visit the following additional procedures will be performed
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation
You may complete a sensory test This test will take about 10 minutes to complete
End-of-Treatment Visit at about 4 months
You will fill out the 4 questionnaires in the clinic or by telephone about your symptoms It should take about 15-20 minutes to complete all of the questionnaires
The study staff will make a count of the number of pills that you took so far
If you return to the MD Anderson or Harris Health clinic for this visit
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation
You may complete a sensory test This test will take about 10 minutes to complete
You must bring the study drugplacebo container along with any remaining drugplacebo
Length of Study
You may continue taking the study drugplacebo for up to 4 months if there are no treatment delays You will no longer be able to take the study drug if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions
Your participation in the study will be over at the End-of-Study visit
End-of-Study Visit
At about 6 months the following tests and procedures will be performed
You will fill out 4 questionnaires in the clinic or by telephone about pain and other symptoms and your quality of life You will also complete a questionnaire about your tobacco history It should take about 15-25 minutes to complete all of the questionnaires
If you return to the MD Anderson or Harris Health clinic for this visit
If possible blood about 6 teaspoons will be drawn to test for markers of inflammation
You may complete a sensory test This test will take about 10 minutes to complete
This is an investigational study Minocycline is FDA approved and commercially available for the treatment of bacterial infection Its use in this study is investigational
Up to 166 participants will be enrolled in this study Up to 83 will be enrolled at the Harris Health System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RSG-13-241-01-PCSM | OTHER | Amercian Cancer Society | None |
| NCI-2014-01291 | REGISTRY | None | None |