Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Antineoplastic Agents

Metformin

Paclitaxel

Albumin-Bound Paclitaxel

Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.

Adaptation phase begins 12 days prior to the start of the Paclitaxel therapy. During this phase, study medication dose starts at 500 mg daily for 5 days, followed by 500 mg twice daily for 5 days, followed by the desired dose of 1,000 mg twice daily for 2 days. Participants reach required study medication dose of 2,000 mg daily 2 days prior to commencement of Paclitaxel therapy and continue this dose for remainder of intervention.

Questionnaires completed about numbness and/or symptoms about 2 weeks before start of Paclitaxel, 1 -2 days before Paclitaxel, every week while taking Paclitaxel, and at end of study visit. At week 12, questionnaire completed regarding satisfaction with Paclitaxel.

Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.

Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.

Questionnaires completed about numbness and/or symptoms about 2 weeks before start of Paclitaxel, 1 -2 days before Paclitaxel, every week while taking Paclitaxel, and at end of study visit. At week 12, questionnaire completed regarding satisfaction with Paclitaxel.

Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.

Metformin dose starts at 500 mg daily for 5 days, followed by 500 mg twice daily for 5 days, followed by 1,000 mg twice daily for 2 days. Participants reach required study medication dose of 2,000 mg daily 2 days prior to commencement of Paclitaxel therapy and continue this dose for remainder of intervention.

Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.

Placebo

Questionnaires completed about numbness and/or symptoms about 2 weeks before start of Paclitaxel, 1 -2 days before Paclitaxel, every week while taking Paclitaxel, and at end of study visit. At week 12, questionnaire completed regarding satisfaction with Paclitaxel.

Questionnaires

Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.

Sensory and Fine-Motor Tests

David L. Ramirez, MD

The goal of this clinical research study is to learn if metformin can help to control nerve damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel in patients with breast cancer.

In this study, metformin will be compared to a placebo. 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.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 2 groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have a 1 out of 3 chance of being in Group 1 and a 2 out of 3 chance of being in Group 2.

* If you are in Group 1, you will take placebo pills.
* If you are in Group 2, you will take metformin pills.

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:

You should take the pills 2 times a day at about the same time every day, preferably with food (for example, with breakfast and dinner).

You will start taking the pills about 12 days before your paclitaxel treatment starts. This is called the "adaptation period." It is meant to allow your body to get used to the study pills. The study staff will check you for allergic reactions or other negative reactions to the pills during this period. If you are not tolerating the pills, you will be taken off study.

About every 3 weeks while you are receiving paclitaxel, you should bring the study drug/placebo container (along with any leftover pills) to the clinic. The study staff will count the number of pills you have taken.

Study Visits:

Every week during the study, either during your clinic visit or by phone, the study staff will ask you about any side effects you may be having, if you have taken the study drug/placebo, and how many pills you have taken so far. The calls should take about 10-15 minutes.

About 2 weeks before you start paclitaxel:

* You will complete questionnaires about numbness and other symptoms. It should take about 15 minutes to complete these questionnaires.
* You will complete 3 sensory and fine-motor tests. These tests will show researchers how sensitive you are to touching things such as small bumps and how well you are able to pick up small objects. It should take about 15 minutes to complete these tests.
* If possible, blood (about 8 teaspoons) will also be drawn to test for markers of inflammation. Markers of inflammation are biomarkers found in the blood and may be related to the symptoms you have. These blood samples during the study will only be collected if they can be drawn during a routine blood draw you are already having.

At 1-2 days before you start paclitaxel:

* You will complete the questionnaires about numbness and other symptoms.
* You will complete the sensory and fine-motor tests.
* Blood (about 8 teaspoons) will be drawn to test for markers of inflammation, if a routine blood sample is also being drawn on that day.

Every week while you are receiving paclitaxel, you will complete a questionnaire in the clinic or by phone about any symptoms you may be having, and how the symptoms may be affecting your daily activities. This questionnaire should take about 5 minutes to complete.

About every 3 weeks while you are receiving paclitaxel, at your clinic visits:

* You will complete the questionnaires about numbness.
* You will also complete the sensory and fine-motor dexterity tests.

At about Weeks 6 and 12 while you are receiving paclitaxel, at your clinic visits, blood (about 8 teaspoons) will be drawn to test for markers of inflammation, if a routine blood sample is also being drawn on that day.

At about Week 12 while you are receiving paclitaxel, at your clinic visit, you will complete a questionnaire about how satisfied you are with the study drug/placebo. Completing the questionnaire should take about 5 minutes.

Length of Study:

You may take the study drug/placebo for up to 12 weeks. You will no longer be able to take the study drug/placebo 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 after the end-of-study visit.

End-of-Study Visit:

About 4 weeks after you finish receiving the study drug/placebo:

* You will complete the questionnaires about numbness and other symptoms.
* You will complete the sensory and fine-motor tests.
* Blood (about 8 teaspoons) will be drawn to test for markers of inflammation, if a routine blood sample is also being drawn on that day.

This is an investigational study. Metformin is FDA approved and commercially available for the treatment of a type of diabetes. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work.

Up to 42 participants will be enrolled in this study. All will take part at the Harris Health System.

Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer

Metformin for Reduction of Paclitaxel Treatment-Related Neuropathy in Patients With Breast Cancer: A Randomized Pilot Study

Change in neuropathy as assessed with the chemotherapy-induced peripheral neuropathy (CIPN) survey QLQ-CIPN20 between T1 and T5 where difference in mean area under the curve (AUC) between groups reported. The AUC for response from T1 to T5 is computed by fitting a series of trapezoids to the QLQ-CIPN20 data assessed at T1, T2, T3, T4, and T5, respectively, and summing up their areas \[AUC calculated - base of a trapezoid corresponds to the number of days between assessments, and the heights correspond to two adjoining symptom responses, number of trapezoids depends on number of symptom assessments and sum of area for all trapezoids represents AUC of particular participant\]. QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much") with the higher score denoting more symptom burden.

M.D. Anderson Cancer Center

Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.

Metformin Group

Placebo Group

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. David L. Ramirez, Assistant Professor, Breast Medical Oncology

Study stopped early with only one participant, analysis not possible.

Mean Change in Neuropathy

Overall Study

Nervous System Diseases

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Peripheral Nervous System Diseases

Pain

Hypesthesia

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Acute Graft Versus Host Disease

Anti-Infective Agents

Minocycline

Anti-Bacterial Agents

Group 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.

Group 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.

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

1 placebo by mouth for the first day of chemotherapy, then 1 dose 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.

Sensory Test

Cathy Eng, MD, BA

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.

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.

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

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

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.

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.

American Cancer Society, Inc.

Minocycline 100 mg twice a day during 4 months

Placebo 100 mg twice a day during 4 months

Age, Continuous

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. James Yao, MD, Director of GI Medical Oncology

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

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

Patients with advanced cancer entering chemotherapy or have reported pain as a result of cancer treatment.

Tests to find the threshold at which perceive stimuli.

Sensory Tests

Patrick M. Dougherty, PhD

The Aim of this Study is to examine the feasibility of using quantitative sensory testing procedures, widely applied to the experimental study of sensory processing in humans both with and without various pain syndromes, to now characterize the psychophysical properties of neuropathic pain that has developed as a consequence of cancer therapy. Skin punch biopsies will be performed in patients with chemotherapy-induced pain to determine whether the impairment of nerve function is due to actual retraction or loss of innervation to the skin in areas affected by sensory disturbance.

Study Participation:

Participants will be contacted either before their initiation of chemotherapy or following their referral to pain management service for neuropathic cancer treatment-related pain.

The sensory tests will take about 1 hour to complete. These tests will seek to find the threshold (a measure of sensitivity) at which you perceive stimuli, such as touch, coolness, warmth, hot/cold feeling and pinprick. You will be asked to rate the intensity of each of these stimuli that you perceive to be painful. You will also be asked to rate the intensity of stimuli that are at a fixed intensity above the pain threshold for most people. Your skin temperature using a radiometer, a scan of your fingers and/or toes, grooved peg board, a timed task to place pegs in slots, and pain scale rating will be collected. Each part of the sensory test are optional and will be collected when possible.

You may either be tested at repeated intervals throughout your chemotherapy or at later follow-up dates to check the length of symptoms.

Length of Study:

Your participation will be complete once you have completed all the sensory testing.

Healthy Controls:

Study Participation:

If you agree to take part in this study, you will take part in sensory tests. The sensory tests will take about 1 hour to complete. These tests will seek to find the threshold (a measure of sensitivity) at which you perceive stimuli, such as touch, coolness, warmth, hot/cold feeling and pinprick. You will be asked to rate the intensity of each of these stimuli that you perceive to be painful. You will also be asked to rate how severe the stimuli that are above the level considered painful by most people. Your skin temperature using a radiometer, a scan of your fingers and/or toes, grooved peg board, a timed task to place pegs in slots, and pain scale rating will be collected. Each part of the sensory test are optional and will be collected when possible.

A skin biopsy will also be performed. If you are taking anticoagulants (blood thinners), you may be asked to stop taking them for several days, before the procedure, due to the risk of bleeding. For the skin punch biopsy, the skin is numbed with lidocaine and cleaned with betadine and an alcohol swab. Once the skin is anesthetized (numb), a small amount of skin will be collected using a sterile 3 mm punch tool (knife). After removal of the skin, the area where you were tested will be wiped with a sterile gauze, and antibiotic ointment will be applied. Then, it will be covered with a band aid. You will be given a small supply of antibiotic ointment and band aids. You will be asked to clean the skin with soap and water twice each day and to apply the ointment and band aid.

Researchers will study the skin sample and compare it to skin samples from cancer patients, so that they can try to better understand the cause of pain that occurs because of cancer therapy.

Length of Study:

Your participation will be complete once you have completed the sensory testing and skin biopsy.

Psychophysical Studies of Cancer Therapy Pain

Psychophysical Studies of Cancer Therapy-Induced Pain: A Feasibility Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neuromuscular Diseases

Oxaliplatin

Cisplatin

Bortezomib

Taxane

3 questionnaires to collect information about any pain and/or symptoms experienced, general well-being, and personal information such as age and marital status. One (1) will be a symptom assessment questionnaire where asked to rate symptoms on a scale of 0-10.

Questionnaire

Test of sensitivity to things such as cold and touch, involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board; and marking on computerized drawings areas experience pain, numbness, and/or cold sensitivity.

First 5 patients receiving platinum agents, taxanes, and bortezomib (15 patients total) will be asked to describe their symptoms in an open-ended, semi-structured 20-30 minute interview.

Interview

Charles Cleeland, PHD,BA

The goal of this research study is to learn more about pain and other symptoms that patients may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or bortezomib.

If patient agrees to take part in this study, they will be asked to complete 3 questionnaires, 3 sensory tests, and may be asked to take part in a one-on-one symptom interview.

Symptom Interview:

Depending on when patient is enrolled in this study, they may take part in a one-on-one interview with a study staff member. A total of 15 participants will take part in this interview (5 taking platinum agents, 5 taking taxanes, \& 5 taking bortezomib). During the interview, patient will be asked to describe their symptoms. The interview should take about 20-30 minutes to complete.

The interviews will be digitally recorded, transcribed (typed), and used by researchers to identify symptoms related to receiving this type of chemotherapy. Researchers will use this information to design a study questionnaire that focuses on chemotherapy symptoms in the hands and feet. The digital recordings and typed copies of the interview will be destroyed after researchers have analyzed the interview data and the study is complete.

Questionnaires \& Sensory Tests:

All study participants will complete 3 questionnaires that are designed to collect information about any pain and/or symptoms patient may have experienced, their general well-being, and personal information such as age and marital status. One (1) of them is called a symptom assessment questionnaire and patient be will asked to rate their symptoms on a scale of 0-10.

All study participants will also complete 3 tests, called sensory tests, that are designed to help researchers learn how sensitive patient is to things such as cold and touch. These tests involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board. Patient will also be asked to mark on computerized drawings the areas where they experience any pain, numbness, and/or cold sensitivity. A study staff member will explain how to take the tests and use the computerized drawings in more detail at the time these tests are performed.

It should take about 20-30 minutes to complete all of the questionnaires and tests.

Additional Sensory Testing:

Out of the 200 participants on this study, 40 participants will be asked to return to the clinic for additional sensory testing to help researchers learn if the tools used for this study are working as expected.

This additional testing is designed to help researchers learn how sensitive patient is to things such as touch, cold, warmth, and a pinprick to the finger, hand, or arm. Patient will be asked to describe how well they can feel each test, and how much pain they may or may not feel. This additional testing should take about 60 minutes to complete.

Length of Study:

After patient has completed the interview (if they are asked), 3 questionnaires, and 3 sensory tests their participation on this study will be over. If patient is selected to take part in the additional sensory testing, their participation on this study will be over after those tests are complete.

This is an investigational study.

Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.

Chemotherapy-Induced Peripheral Neuropathy Survey

Chemotherapy-Induced Peripheral Neuropathy: Feasibility and Validity of New Symptom Measurement Tools in Patients on Treatment With Platinum Agents, Taxanes and Bortezomib

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer	NCT02360059	Breast Cancer	Metformin Placebo Questionnaires Sensory and Fin...	18 Years - 74 Years	M.D. Anderson Cancer Center
Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer	NCT02360059	Breast Cancer	Metformin Placebo Questionnaires Sensory and Fin...	18 Years - 74 Years	M.D. Anderson Cancer Center
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients	NCT01906008	Colorectal Canc...	Minocycline Placebo Questionnaires Sensory Test	18 Years -	M.D. Anderson Cancer Center
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients	NCT01906008	Colorectal Canc...	Minocycline Placebo Questionnaires Sensory Test	18 Years -	M.D. Anderson Cancer Center
Psychophysical Studies of Cancer Therapy Pain	NCT00515060	Advanced Cancer Pain	Sensory Tests	18 Years -	M.D. Anderson Cancer Center
Chemotherapy-Induced Peripheral Neuropathy Survey	NCT01016028	Breast Cancer Colorectal Canc... Myeloma Chemotherapy-in...	Questionnaire Sensory Tests Interview	18 Years -	M.D. Anderson Cancer Center

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