AzTrials
AzTrials

Colorectal CancerPhase 2NCT01906008

Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients

A Phase 2 study testing Minocycline, Questionnaires and Sensory Test in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical research study is to learn if minocycline can reduce numbness, pain, and/or 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Minocycline, Questionnaires and Sensory Test
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
2 sitesUnited States
Study dates
Nov 2013to 14 Feb 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a pathologically proven diagnosis of CRC seen either at MD Anderson or LBJ.
  • Patients > or = 18 years old.
  • Patients who qualify for oxaliplatin-based chemotherapy (in the adjuvant or metastatic setting) and are likely to receive at least 3 months of oxaliplatin.
  • Patients who speak English or Spanish (due to language options for the MDASI version being used in this study, we are only recruiting English-speaking or Spanish-speaking patients).
  • Patients with an NCI-CTCv4 sensory neuropathy score of 0.
  • Patients with adequate renal function (serum creatinine must be < 1.5 times the upper limit of the institutional normal range) and no prior renal disease that in the opinion of the attending physician would make the patient ineligible to receive the study drug . Test results must be no more than 3 months old.
  • Patients with adequate hepatic function (total bilirubin must be < 2.0 times the upper limit of the institutional normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be < 3.0 times the upper limit of the institutional normal range). Test results must be no more than 3 months old.
  • Patients willing and able to review, understand, and provide written consent.

Who cannot join

  • Patients continuously taking any minocycline within the last 15 days. Patients who have conditions that potentially preclude use of minocycline as determined by the treating physician.
  • Patients continuously taking systemic steroids within the last 15 days.
  • Patients with autoimmune disorders (for example, systemic lupus erythematosus or rheumatoid arthritis), who have been treated in the last 3 years.
  • Patients who are pregnant; the absence of pregnancy will be confirmed by negative urine test.
  • Hypersensitivity to any tetracyclines, or a history of other allergies or drug reactions that in the treating physician's judgment make the patient inappropriate for this study.
  • Patients receiving vitamin K antagonist (warfarin).
  • Patients with a BMI >40 (Obese Class III criteria).
  • Patients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapy.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • LBJ Hospital

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II, Randomized, Placebo-Controlled Study of Minocycline for Reducing Symptom Burden in Patients With Colorectal Cancer

The goal of this clinical research study is to learn if minocycline can reduce numbness, pain, and/or 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.

Read the detailed description

Nearly 40% of patients with colorectal cancer who receive oxaliplatin-based chemotherapy experience neuropathy (nerve damage that can include numbness, pain, and/or 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 drug/placebo capsule by mouth, twice a day every day.

You should take the study drug/placebo 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 drug/placebo to reduce the risk of side effects.

Study Visits:

Before you start taking the study drug/placebo:

  • 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 drug/placebo container (along with any remaining drug/placebo).

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 drug/placebo container (along with any remaining drug/placebo).

Length of Study:

You may continue taking the study drug/placebo 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.

Being tested
Minocycline, Placebo, Questionnaires, Sensory Test
Keywords
Colorectal cancer, CRC, Acute peripheral neuropathy, Numbness, Pain, Loss of motor function, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn, Placebo, Questionnaires, Surveys, Sensory tests
Medical subject headings
Colorectal Neoplasms, Hypesthesia, Pain, cyclopia sequence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MinocyclineDrug

    Also called Dynacin, Minocin, Minocin PAC, Myrac

    200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for 4 months beginning at chemotherapy initiation.

  • PlaceboDrug

    1 placebo by mouth for the first day of chemotherapy, then 1 dose every 12 hours for 4 months beginning at chemotherapy initiation.

  • QuestionnairesBehavioural

    Also called Surveys

    Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit.

  • Sensory TestBehavioural

    Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.

Study groups in NCT01906008
Study groupRoleWhat they receive
MinocyclineExperimentalGroup 2 receives minocycline 200 mg orally for the first dose, then 100 mg orally every 12 hours for 4 months beginning at chemotherapy initiation. Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit. Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.
Receives: Drug: Minocycline; Behavioral: Questionnaires; Behavioral: Sensory Test
PlaceboPlacebo comparatorGroup 1 receives a placebo 200 mg orally for the first day of chemotherapy, then 100 mg doses every 12 hours for 4 months beginning at chemotherapy initiation. Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit. Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.
Receives: Drug: Placebo; Behavioral: Questionnaires; Behavioral: Sensory Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months

    AUC for MDASI-numbness/tingling . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0*120) to 1200 (10*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.

    Measured: Baseline to 4 months

Secondary outcomes (1)

  1. Average Area Under the Curve (AUC) for Fatigue Over 4 Months

    AUC for MDASI-fatigue . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0*120) to 1200 (10*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.

    Measured: Baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion14 Feb 2019
  4. Study completion14 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01906008
Sponsor's protocol ID
2013-0323
Other IDs
NCI-2014-01291, RSG-13-241-01-PCSM
Status last verified
Mar 2020
First submitted
18 Jul 2013
Last updated
17 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Minocycline, Questionnaires and Sensory Test in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01906008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in