Nervous System Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

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

All Drugs and Chemicals

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.

Placebo

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.

Questionnaires

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.

M.D. Anderson Cancer Center

Minocycline 100 mg twice a day during 4 months

Placebo 100 mg twice a day during 4 months

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

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

Overall Study

Behaviors and Mental Disorders

Pain, Postoperative

Chronic Pain

Phantom Limb

Sensation Disorders

Postoperative Complications

Neurologic Manifestations

Perceptual Disorders

Neurobehavioral Manifestations

Chronic Graft Versus Host Disease

Nipple sparing mastectomy (NSM) and implant reconstruction

Nipple sparing mastectomy (NSM) and autologous reconstruction

Gender mastectomy with free nipple grafting

Control patients matched by surgical procedure, age, BMI and mastectomy weight.

Quantitative sensory testing (QST) will be performed. QST was developed to standardize the noninvasive assessment of the somatosensory nervous system and quantify functioning of all aspects of sensation (light touch, pressure, warm, cold, pain, vibration): 1. Thermal detection (Medoc TSA system): Cold detection threshold B) Warm detection threshold C) Heat pain threshold 2. Mechanical detection threshold (MRC Opti Hair von Frey Filaments) 3. Two-point discrimination (MRC Opti Hair von Frey Filaments) 4. Mechanical pain threshold (MRC Pinprick Stimulator) 5. Pressure pain threshold (Medoc Pressure algometer) 6. Tinel sign on physical exam 7. Vibration (tuning fork)

Sensory testing

Lisa Gfrerer, MD, PhD

Lisa Gfrerer, MD. PhD

During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.

SIGNIFICANCE

During removal of breast tissue that is required for mastectomy procedures, the nerves that supply the breast skin and the nipple areola complex (NAC) are sacrificed. This results in fair to poor sensation in 50-90% of patients, decreased patient satisfaction and increased risk of injury. Further, when nerves are transected, axons sprout from the proximal free nerve end and form neuromas that cause chronic pain (CP) and phantom pain (PP) in \~60% and 30-80% of patients, respectively. With the implementation of advanced peripheral nerve surgery techniques, it has become possible to preserve, transfer and graft nerves to the insensate areas of the reconstructed breast/chest to provide sensation in cancer and transgender patients. Multiple studies have shown increased patient satisfaction and sensation after reinnervation as compared to no reinnervation. However, there are several limitations to currently published clinical outcome studies: 1)Lack of comprehensive objective outcome measures to test all aspects of the somatosensory nervous system. No study to date has utilized the protocol for Quantitative Sensory Testing (QST) that was developed by the German Research Network on Neuropathic Pain (DFNS) and provides a validated and standardized approach to test all nociceptive and non- nociceptive sensory functions including small unmyelinated C fibers, myelinated A-alpha, A-beta, and A-delta fibers. This comprehensive, standardized and validated approach has been adopted internationally to evaluate sensory conditions and allows for objective outcome assessment and comparison. 2)Gap in knowledge regarding reinnervation outcomes after implant- based reconstruction. Most sensory studies were performed in patients undergoing autologous reconstruction with only few studies discussing reinnervation in the context of implant- based breast reconstruction. However, the most common type of reconstruction after breast cancer remains implant based reconstruction accounting for 80% of breast reconstruction cases. Therefore, it is important to investigate this population further to determine whether reinnervation is successful and should be offered to this patient population. 3)Limited understanding of sensory outcome after transgender mastectomy. Sensory outcome is important to \>90% of patients undergoing transgender mastectomy with free nipple grafting (FNG), which is the most common procedure performed in transgender patients. Our team has described chest reinnervation in this patient population with good sensory outcomes. However, a prospective clinical trial with comprehensive outcome measurements including QST and patient reported outcome measures (PROMs) with control group is required to further examine the role of reinnervation in transgender chest surgery. 4)Insufficient prospective data on PP and CP. There are very few prospective studies reporting the incidence of PP and CP after cancer and transgender mastectomy and the results are inconsistent. Further, the percentage of chronic breast/chest pain patients with true neuropathic pain (NP) is unclear. In addition, although we know from other patient populations (amputees) that nerve reconstruction significantly decreases the incidence of CP and PP, there is no data on whether breast reinnervation influences the percentage of patients who will develop these conditions. 5)Prospective comparison of reinnervation outcomes between autologous reconstruction, implant reconstruction and gender mastectomy has not been performed. Breast reinnervation has rapidly evolved and is becoming a widely employed addition to breast and chest reconstruction. However, it remains unclear how these patient populations compare, and which patients obtain good sensory outcome warranting the longer operative times and higher cost of reinnervation.

The broad objective of this proposal is to prospectively compare objective data on sensory outcomes using QST and PROMs in patients undergoing reinnervation after A) nipple sparing mastectomy (NSM) and implant reconstruction B) NSM and autologous reconstruction C) gender mastectomy with FNG and D) control patients matched by surgical procedure, age, BMI and mastectomy weight. This preliminary data will be used to apply for government funding (NIH K23) to conduct a randomized controlled multi- center clinical trial to evaluate reinnervation versus no reinnervation after mastectomy in cancer and transgender care. The objectives of this larger scale study are to A) obtain objective QST sensory measurements and PROM outcomes across institutions, B) determine the chances of reinnervation success based on variables such as patient factors (age, comorbidities, adjuvant treatment), mastectomy factors (incision type, mastectomy weight), breast reconstruction techniques (retropectoral, prepectoral, direct- to implant, expander reconstruction, implant size, implant type, types of autologous reconstruction), chest reconstruction techniques and nerve transfer techniques (number of nerves, length of allograft, size of allograft etc.) C) perform a cost- benefit analysis and D) develop evidence-based guidelines for breast/ chest reinnervation after mastectomy.

SPECIFIC AIMS

All aims will analyze and compare the following patient groups: a) NSM and implant reconstruction with reinnervation b) NSM with autologous reconstruction with reinnervation c) gender mastectomy with FNG with reinnervation d) controls matched by surgical procedure (implant, autologous, transgender), BMI, age, gender and mastectomy weight.

Aim 1A: Analysis of all aspects of sensation with QST. Aim 1B: Evaluation of timing of return of sensation. Aim 2: Assessment of CP and PP. Aim 3: Analysis of patient satisfaction.

HYPOTHESIS

Breast reinnervation does not improve sensation/patient satisfaction as compared to mastectomy with no reinnervation. Further, there is no difference in prevalence of CP and PP.

Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients

Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.

All BREAST-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.

All Gender-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.

Thermal detection measured by Medoc TSA system

Measured by MRC Opti Hair von Frey Filaments

Massachusetts General Hospital

Weill Medical College of Cornell University

Neuromuscular Diseases

Quality of Life

Central Nervous System Depressants

Ethanol

16 patients will be randomized to receive verum acupuncture two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.

16 patients will be randomized to receive sham acupuncture two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.

Patients will lay supine. The acupuncture physicians will disinfect the selected acupuncture points with alcohol and then needle them (30 gauze, 1.5-inch, Yuguang, Taiwan) with a plastic device is fixed needle body, so that the patient achieves a "de qi" sensation, which is often described as a pressure or achiness feeling. The acupuncture point will be bilateral Quchi, Waiguan, hegu, baxie, Zusanli, Yanglingquan, Sanyinjiao, Taichong, bafeng. Acupuncture needles will be left in place for approximately 30 minutes, and every 10 minutes twisting stainless steel needle to get a "de qi".

Verum acupuncture

Tzu-Liang Chen, M.D., MS.

Ming-Cheng Huang, M.D

The aim of this pilot study is to investigate the efficacy of acupuncture in prevention of chemotherapy induced peripheral neuropathy. The study adapted a single center, randomized, assessor- and participant-blinded, controlled, and parallel-design approach to investigate whether acupuncture can prevent or postpone the occurrence of peripheral neuropathy and improve quality of life.

Background and purpose:

Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling side effect of several commonly used antineoplastic agents. CIPN prevalence was 68.1% within the first month of the end of chemotherapy, 60% at 3 months, and 30.0% at 6 months or later. Oxaliplatin as a chemotherapeutic drug for colorectal cancer has neurotoxicity on peripheral nerve system. A definite portion of patients suffered neurologic symptoms including paresthesia, dysesthesia over limbs and perioral area accompanied with muscles cramps or spasm sometimes; however, had impact on quality of life, daily functions, quality of sleep and lead to distress and depression. There is no drug to prevent peripheral neuropathy. Clinical observations reveal that acupuncture could decrease peripheral neuropathy, improve quality of life, and promote motivation of complete chemotherapy course.

Material and methods:

A total of 32 volunteers of patients with colorectal cancer will be recruited from the Chinese medicine or Western medicine clinics in China Medical University Hospital. These patients will be randomized to receive verum acupuncture or sham acupuncture treatment two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.

Questionnaires, neurological examination and Von Frey Filament Test will be completed at baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.

Predict results:

Investigators expect that the efficacy of verum acupuncture is superior to sham acupuncture in prevent or postpone occurrence of chemotherapy induced peripheral neuropathy and able to improve numbness, paresthesia, quality of life. The effectiveness of acupuncture can be detected by questionnaires, Von Frey Filament Test and neurological testing.

Efficacy of Acupuncture in Prevention of Chemotherapy Induced Peripheral Neuropathy - a Pilot Study

Randomized, Assessor- and Participant-blinded, Controlled, and Parallel-design Approach to Investigate Whether Acupuncture Can Prevent or Postpone the Occurrence of Peripheral Neuropathy and Improve Quality of Life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients	NCT06094257	Sensation Disor... Sensation, Phan... Pain, Postopera... Pain, Chronic Numbness Sensory Disorde... Sensory Defect Phantom Pain Phantom Sensati...	Sensory testing	18 Years -	Weill Medical College of Cornell University
Efficacy of Acupuncture in Prevention of Chemotherapy Induced Peripheral Neuropathy - a Pilot Study	NCT02744274	Colorectal Canc...	Verum acupunctu...	20 Years - 70 Years	China Medical University Hospital
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
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients	NCT06094257	Sensation Disor... Sensation, Phan... Pain, Postopera... Pain, Chronic Numbness Sensory Disorde... Sensory Defect Phantom Pain Phantom Sensati...	Sensory testing	18 Years -	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for numbness

Every month we try and update this database with for numbness cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for numbness

Every month we try and update this database with for numbness cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for numbness cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.