Intraneural Facilitation (INF) treatment is an effective way to restore blood flow to damaged nerves as neuropathy is strongly impacted by reduced blood flow.

subjects will receive a standardized program of muscle stretching and strengthening exercise twice a week for six weeks under the supervision of treating physical therapist

Chemotherapy-induced Peripheral Neuropathy

Women aged ≥ 18 years at signing of informed consent

INF utilizes three holds or positions, which widens tiny openings in arteries surrounding nerves and improves blood flow to targeted nerves. The improved blood flow in these nerves stimulates healing and reduces or even stops nerve pain.

Arm 1: Investigational INF

subjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist.

Arm 2: standardized muscle stretching and strength

Loma Linda Medical Center

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy

The 20 item PQAS measures self reported aspects of nociceptive and neuropathic pain (intensity, sensation, depth, location) on a scale of 0 to 10.

Study participants self report distress based on National Comprehensive Cancer Network's Distress Thermometer (DT) measures distress on a scale of 0 = no distress, 10=extreme distress.

The MSNI is a physical screening instrument of the lower legs and feet for the assessment of neuropathy using visual inspection, vibration sensation, ankle reflexes and monofilament testing producing a score of 0 being normal and 10 meaning significant neuropathy as measured by the assessing physical therapist

The CTCAE measures peripheral sensory neuropathy on a scale of 1=asymptomatic to 5=death as measured by the treating physician

Ultrasound imaging will be administered before and after treatment on the measurement days for subjects in both Arm 1 and Arm 2

The completion and premature discontinuation rates due to peripheral neuropathy for each subject will be counted for each Arm.

The dose reductions in chemotherapy due to peripheral neuropathy for each subject will be measured for each Arm.

A written survey of 10 questions regarding subject acceptance, burden and satisfaction will be administered to each subject in both Arms at the end of treatment.

Gayathri Nagaraj

Primary Investigator / Sponsor

Loma Linda University

Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.

Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.
Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.

Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.
Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)

Placebo

Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.
Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.
0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.
(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.

0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone

Total

Sex: Female, Male

Region of Enrollment

The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail:
Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5.
PMID: 10740540

Quality of Recovery Score

A study-specific pain form was provided to the patient and nursing staff that consisted of standard visual analogue scale (VAS) for patients to rate their pain level. Pain level was rated as a categorical level from 0 to 10, in 1 unit increments, with 0 being "no pain at all" and 10 being "worst pain imaginable." Thus a total of 10 pain grades were possible.

Pain Score Using 10-point Visual Analog Scale (VAS)

Total opioid consumption in the first 24 hrs of recovery after surgery as measured in "morphine equivalents." This involves converting the dose of a non-morphine narcotic (e.g. IV hydromorphone or oral hydrocodone) into the equi-analgesic dose of morphine, so that the total amount of narcotic utilized by the patient can be compared. This is a standard technique for comparison utilized in the pain management literature.

Opioid Consumption

Number of postoperative days patients stay in the hospital after surgery

Length of Hospital Stay

Overall Study

Dr. Mohammed Alghoul

Breast Cancer

If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)

Saline

If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.
(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.

0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone

Northwestern University

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

Does Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction Reduce Postoperative Pain and Opioid Requirement?: A Prospective Double-Blinded Randomized Controlled Trial

Mohammed Alghoul

Assistant Professor

The intervention condition will receive the same guidelines as the comparison condition but will also be provided with family physical activity planning material.

The standard (comparison group) package will consist of Canada's family guide to physical activity guidelines recommending 60 minutes of activity a day in bouts as short as five to ten minutes for children and a breakdown of ways for the family to achieve this physical activity (structured, unstructured, endurance, strength, activities, less than 60 minutes of sustained sedentary activity, reduce screen viewing by 30 min per day) commensurate with this guide. This will include the new insert by CSEP. The guide also contains arguments and information about the benefits of physical activity.

Physical Activity

This material will include skill training content (workbook how to plan for family physical activity) and practical material to create a plan (i.e., a colourful dry erase wall calendar for family activities with fridge magnets). The skill training material for planning is based on several streams of prior work in the adult physical activity literature. Families were instructed to plan for "when," "where," "how," and "what" physical activity will be performed commensurate with the creation of implementation intentions/action planning. The workbook, however, also focuses on problem solving barriers to physical activity which is more akin to coping planning and traditional goal setting.

Family physical activity planning

Behavioural Medicine Laboratory

Family Planning to Promote Regular Physical Activity

Family Planning to Promote Regular Physical Activity: A Randomized Controlled Trial

Children's physical activity will be quantified by accelerometry. Children will wear an accelerometer for a minimum of 10 hours per day for 7 days at baseline and 6 months. Additionally this measure will assess intermediate outcomes at 6 weeks and 3 months.

Parent's physical activity will be quantified by accelerometry. Parents will wear an accelerometer for 7 days at baseline, 6 weeks, 3 and 6 months, for a minimum of 10 hours per day.

Motivations for family based physical activity and personal physical activity will be measured using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. The Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) will be completed by both parents and the target child. Change in motivation variables will be examined (6 weeks minus baseline).

The target child will complete a modified version of the Physical Activity Questionnaire for Children (PAQ-C) to assess habitual moderate to vigorous physical activity. The Godin Leisure-Time Exercise Questionnaire (LSI) will be used to measure self-reported physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (6 weeks minus baseline).

Quality of life will be assessed with parents using the Satisfaction with Life Scale and the 12 item Short Form Health Survey. The target child's quality of life will be assessed using the 5-item Satisfaction with Life Scale Adapted for Children (SWLS-C). Change in health-related quality of life/ psychosocial distress from baseline to 6 months (i.e., post-intervention) will be examined.

The physical home environment will be assessed using three sections from the Active Where surveys (i.e., Section A. equipment checklist, Section P. Home Environment, & Section R. Sedentary Behavior). The Active Where surveys include items designed to to assess how the physical environment impacts the physical activity and eating behaviors of youth. Change in physical environment will be examined from baseline to 6 months (post-intervention).

Skinfolds (triceps, biceps, subscapular, supra iliac, medial calf) will be measured using standard anthropometric procedures. Change in body mass index (BMI), waist circumference, and sum of 5 sites will be examined from baseline to 6 months (post-intervention)

A single state treadmill walking test will be used to assess cardiovascular fitness in both parents and target child. Heart rate, and blood pressure (sphygmomanometer and a stethoscope) will be monitored at rest and during exercise. Change in cardiovascular fitness from baseline to 6 months (i.e., post-intervention) will be examined.

Motivations for physical activity will be using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. The BREQ-2 will be completed by both parents and the target child. Change in motivation variables will be examined (3 months minus baseline).

The target child will complete a modified version of the PAQ-C to assess habitual moderate to vigorous physical activity. The LSI will be used to measure self-reported physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (3 months minus baseline).

Motivations for physical activity will be using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. The BREQ-2 will be completed by both parents and the target child. Change in motivation variables will be examined (6 months minus baseline).

The target child will complete a modified version of the PAQ-C to assess habitual moderate to vigorous physical activity. The LSI will be used to measure self-reported physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (6 months minus baseline)

Physical activity habits will be measured using 4 items.

Strategies for planning family based physical activity and personal physical activity will be measure using 12 items. Changes in strategies and goal commitment will be examined (6 weeks minus baseline).

Strategies for planning family based physical activity and personal physical activity will be measure using 12 items. Changes in strategies and goal commitment will be examined (3 months minus baseline).

Strategies for planning family based physical activity and personal physical activity will be measure using 12 items. Changes in strategies and goal commitment will be examined (6 months minus baseline).

Grip strength, push ups, sit & reach flexibility, partial curl-ups, vertical jump,and back extension will be measured to determine the musculoskeletal fitness of both the children and parents using the Canadian CSEP standardized protocols. Change in musculoskeletal fitness from baseline to 6 months (i.e., post-intervention) will be examined.

Ryan Rhodes

Professor

University of Victoria

Canadian Institutes of Health Research (CIHR)

Dalhousie University

University of British Columbia

Autologous Stem Cell Transplant will be performed on eligible patients

Allogeneic Stem Cell Transplant will be performed on eligible patients

Autologous Stem Cell Transplant will be performed on eligible patients
Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning

Autologous Stem Cell Transplant

Allogeneic Stem Cell Transplant will be performed on eligible patients
Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning

Allogeneic Stem Cell Transplant

Survival

Dr Richard Burt

Vasculitis

Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning

Allogeneic Stem Cell Transplant will be performed after conditioning

Cyclophosphamide

A rabbit polyclonal antibody to lymphocyte

ATG (rabbit)

G-CSF

Humanized monoclonal antibody against CD52 antigen

Campath-1h

Fludarabine

Tacrolimus

Mesna is a drug used to protect the bladder from the effects of the chemotherapy drugs

Mesna

Northwestern University, Feinberg School of Medicine

Hematopoietic Stem Cell Support in Vasculitis

High Dose Immune Suppression With Hematopoietic Stem Cell Support in Refractory Vasculitis, Necrotizing Vasculitis, Neurovascular Behcet's Disease, and Sjogren's Syndrome

chills/breast neoplasms

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

Family Planning to Promote Regular Physical Activity

Hematopoietic Stem Cell Support in Vasculitis

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