Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Pancreatic Neoplasms

Cancer Pain

Pain

Abdominal Pain

Visceral Pain

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Nociceptive Pain

Neurologic Manifestations

Pancreatic Cancer

This arm provides active 1Hz repetitive TMS (rTMS) applied to SII

This arm provides sham 1Hz repetitive TMS (rTMS) applied to SII

1Hz repetitive transcranial magnetic stimulation for 10 days 26 minutes each day

Transcranial Magnetic Stimulation

Felipe Fregni, MD, PhD

This is a phase II study that aims to investigate prospectively a new therapy for a cohort of patients with chronic pain attributed to pancreatic cancer. The justification of this study is that the pain is the most important factor for the quality of life of these patients and rTMS has been shown to be significantly associated with pain improvement in patients with abdominal pain due to chronic pancreatitis. This therapeutic trial will be a 10-day, randomized, parallel-group design, double-blind, incomplete cross-over, placebo controlled clinical trial conducted at Beth Israel Deaconess Medical Center. The principal aim of this investigation is the study of pain after a therapeutic intervention. The primary outcome is pain reduction indexed by pain reduction and or analgesic intake reduction. The second aim of the study is to assess the safety this new treatment in patients with pancreatic cancer. The third aim of this study is to investigate whether rTMS treatment is associated with a change in the activity of right secondary somatosensory cortex using magnetic resonance spectroscopy. Because patients with locally advanced or advanced pancreatic cancer often require increasing doses of narcotic pain medications, such as morphine, oxycodone and fentanyl, in order to control their pain, adverse side effects are frequent observed in this population of patients. Therefore rTMS treatment might represent a new therapeutic approach that might be useful not only for pancreatic cancer but also to other types of cancer.

The primary aim of this protocol is to investigate a possible novel treatment for visceral pain in patients with locally advanced or advanced pancreatic cancer. Pain is a major contributor to the poor quality of life in patients with pancreatic cancer. Most patients with locally advanced or advanced pancreatic cancer have abdominal pain that requires treatment with increasing doses of narcotic pain medication. The refractory nature of pancreatic cancer pain to pharmacologic therapy led us to hypothesize that one mechanism leading to pain in these patients is dysfunction of brain cortical regulation of visceral sensation. This notion is supported by the finding that deep electrical stimulation of the brain can produce pain relief in patients with intractable pain due to progressive cancers of various types. In addition, patients with pancreatitis, a non-malignant pancreatic condition causing chronic pain, can continue to experience disabling pain even after total pancreatectomy. These finding suggests that pain symptoms in pancreatic cancer can be sustained by a pancreas-independent, neural-based mechanisms in the brain.

Visceral sensation is processed in the secondary somatosensory area (SII). Therefore, pancreatic cancer pain may be sustained by dysfunction of SII rather than by local effects of the cancer alone. We hypothesize further, that dysfunction of SII is one of hyper-excitability. According to this hypothesis, suppression of SII activity may help control the pain in patients with pancreatic cancer and may provide synergy with pharmacologic treatment.

Temporary inhibition of SII activity can be obtained by a novel, non-invasive procedure called transcranial magnetic stimulation (TMS). TMS can suppress brain excitability beyond the duration of the direct application of TMS if appropriate stimulation parameters are utilized. This hypothesis is supported by a sham controlled, double blind pilot trial of 5 subjects with idiopathic chronic pancreatitis: active rTMS applied to SII resulted in significant pain improvement in three of the subjects while sham did not provide any benefit in any of these patients. Furthermore, recent evidence suggests that stimulation of other brain areas, such as the dorsolateral pre-frontal cortex, can modulate acute, experimentally invoked pain (Graff-Guerrero et al 2005).

We will rigorously test the hypothesis that pain due to pancreatic cancer is sustained by dysfunction of SII characterized by hyperexcitability through two specific aims:

1. The first aim of this study is to examine whether 1Hz repetitive TMS (rTMS) applied to SII for ten days during two consecutive weeks in patients with abdominal pain due to pancreatic cancer has an analgesic effect.

   1. The primary outcome for this aim is the difference in pain score level on the Visual Analogue Scale at Day 11 and at Day 28 compared to the week before rTMS. The null hypothesis is that there is no difference in pain score between pre and post-treatment.
   2. The secondary outcome for this aim is to assess the difference in the use of narcotics for pain control on Day 11 and Day 28 compared to Day 1. The null hypothesis is that there is no difference in narcotic use (in IV morphine equivalency units) between pre and post-treatment.
2. The second aim of the study is to assess the safety of rTMS in patients with pancreatic cancer.
3. The third aim of this study is to investigate whether rTMS treatment is associated with a change in the activity of right SII using magnetic resonance spectroscopy. Therefore we will compare the levels of these substances between the two different time points (baseline and post-treatment) and between left and right SII. We expect a decrease in the excitatory neurotransmitters levels (Glutamine - Glx) in the stimulated area as a result of the inhibitory rTMS.

SAFETY In a pilot study of chronic pancreatitis patients, no subject experienced adverse effects from a single session of rTMS. Subjects in an ongoing study of a 10-day course or rTMS in chronic pancreatitis patients also have not experienced adverse events (10 patients thus far). Fifteen-day courses of rTMS have been used for the treatment of various neuropsychiatric diseases without any complications if safety guidelines are carefully followed. We will adhere to the current safety recommendations for rTMS endorsed by the International Society for Transcranial Stimulation and the International Federation for Clinical Neurophysiology. Therefore, we hypothesize that the proposed rTMS protocol will be safe for our patient population.

TMS for the Treatment of Pancreatic Cancer Pain

The Effect of a 10-day Course of Transcranial Magnetic Stimulation on Abdominal Pain in Patients With Locally Advanced and Advanced Pancreatic Cancer, a Randomized Phase II Study.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Beth Israel Deaconess Medical Center

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Nausea

Vomiting

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Postoperative Complications

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Dexamethasone

Dexamethasone acetate

Granisetron

a surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation.

At the start of skin closure, saline (3 ml) was administered i.v.

Group Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.

At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v.

Group Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.

At the start of skin closure, saline (3 ml) was administered i.v.

Transcutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China)

electric stimulation therapy

Jun Zhang, PhD

Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.

186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.

Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery

the frequency and dose of postoperative antiemetics

Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery

Fudan University

Professor

Mouth and Tooth Diseases

Head and Neck Neoplasms

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

TENS Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux); TENS treatments (50Hz / pulse duration of 250 ms / high intensities tolerated / continuously for 20 minutes / 2 sessions a week / 4 weeks / total of the 8 TENS sessions) and Post-test evaluations.

Control Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux) and Post-test evaluations.

TENS

Currently, cancer is a disease of high incidence, already considered a public health problem. Among the most prevalent are head and neck neoplasms, and depending on the location and extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that have a great impact on the quality of life. Radiation therapy is a frequently chosen treatment, and depending on the dose of radiation, causes changes such as hyposalivation. There are techniques for salivary flow stimulation, however, most of the options involve the use of medications, which limits administration to part of the patients. Transcutaneous electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary flow, however there is a limited number of studies that have tested this technique after radiotherapy. The aim of this study was to verify the effect of TENS in increasing the salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The sample will have 80 patients randomly divided into two groups: TENS group and Control group. In both groups, a quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS is effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.

The sample will have 80 patients randomly divided into two groups: 1) TENS group; 2) control group. A quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.

Eletric Stimulation for Hipossalivation Induced by Radiotherapy

Transcutaneous Electric Nerve Stimulation (TENS) Treatment for Hipossalivation Induced by Radiotherapy

Irmandade Santa Casa de Misericórdia de Porto Alegre

Federal University of Health Science of Porto Alegre

Behaviors and Mental Disorders

Fatigue

Dyssomnias

Parasomnias

Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Patients receive non-invasive neurostimulation through the Nesa device

Non-invasive Neuromodulation

The same protocol described for the experimental group will be applied, but electrical stimulation device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.

Placebo Non-invasive Neuromodulation

Gabriel Amengual Jaume, MSc

Raquel Medina -Ramírez, PhD

David Alamo-Arce, MSc

Rafael Arteaga-Ortiz, PhD

Aníbal Báez-Suárez, PhD

Fabiola Molina Cedrés, MSc

María del Pino Quintana-Montesdeoca, PhD

Cancer is a disease, or a set of diseases, that increased in our society. However, improvements in their detection and treatment increase the number of patients who survive. Every year 2.6 million people are diagnosed in the European Union and 1.4 million become cancer survivors. However, these people suffer the late adverse effects of treatment that can seriously affect their quality of life.

the most common late effects are pain, fatigue, and sleeping difficulties. These are estimated between 58-90%. The autonomic nervous system (ANS) appears to play an important role in the manifestation and perpetuation of these symptoms.

This study aims to evaluate NESA (or NESA non-invasive neuromodulation) to treat the most common long-term side effects in cancer survivors, due to the most used treatments.

It will be compared between two groups of cancer survivors. The intervention group, with electrical stimulation, and the sham group, without electrical stimulation emission. The subjects will be assigned randomly. Neither the patient, the therapist, nor the analysts/researchers will know the assignment.

Finally, this project aims to add a passive tool to the therapeutic arsenal of health professionals in the oncology field for the treatment of late side effects.

Effectiveness of NESA in the Treatment of Cancer Survivors

Effectiveness of NESA in the Treatment of Sleep Problems, Fatigue, and Neuromuscular Pain in Cancer Survivors.

The investigators want to see if there are improvements in the quality, efficiency, and quantity of sleep. The Pittsburgh Sleep Quality Index (PSQI) will be combined to report changes in the patient's sleep quality.

Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep

The Short Form 36 (SF-36) health questionnaire will be used. It is a generic scale that provides a profile of health status and is applicable to both patients and the general population.

It is composed of 36 questions (items) that assess both positive and negative states of health. The scores for each of the 8 dimensions of the SF-36 range from 0 to 100, with 100 indicating optimal health and 0 reflecting very poor health.

It is a self-report questionnaire that allows to give a good description of the quality and intensity of the pain they are experiencing. of the quality and intensity of the pain they are experiencing. It consists of a list of 78 words in 20 sections related to pain. Users mark the words that best describe their pain. users mark the words that best describe their pain. These words correlate with different aspects of pain different aspects of pain, including a sensory section (sections 1 to 10), an affective section (sections 11 to 15), an evaluative section (sections 11 to 15), and a 10), an affective section (sections 11 to 15), an evaluative section (section 16), and finally a miscellaneous section (section 16). and, finally, a miscellaneous section (sections 17 to 20).

The main component of the McGill Pain questionnaire consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe

Aníbal Báez Suárez

Clinical Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Incontinence

Prostatic Neoplasms

Enuresis

Nocturnal Enuresis

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions.

After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).

Patients will be instructed to carry on exercises at home for the following 11 months.

Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions.

After surgery: Patients will be instructed to carry on pelvic floor exercises at home for the year after prostatectomy.

After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).

BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises

Carlo Cisari, prof.

Carlo Terrone, prof.

Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only.

The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TMS for the Treatment of Pancreatic Cancer Pain	NCT00324428	Pain Visceral Pain Pancreatic Canc...	Transcranial Ma...	18 Years - 65 Years	Beth Israel Deaconess Medical Center
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery	NCT05408676	Mammary Cancer PONV	electric stimul...	18 Years - 64 Years	Fudan University
Eletric Stimulation for Hipossalivation Induced by Radiotherapy	NCT03151889	Hyposalivation Electric Stimul... Head and Neck N... Radiotherapy	TENS	18 Years - 80 Years	Federal University of Health Science of Porto Alegre
Eletric Stimulation for Hipossalivation Induced by Radiotherapy	NCT03151889	Hyposalivation Electric Stimul... Head and Neck N... Radiotherapy	TENS	18 Years - 80 Years	Federal University of Health Science of Porto Alegre
Effectiveness of NESA in the Treatment of Cancer Survivors	NCT06230679	Cancer Survivor...	Non-invasive Ne... Placebo Non-inv...	18 Years - 80 Years	University of Las Palmas de Gran Canaria
Prevention of Urinary Incontinence After Prostatectomy	NCT00982098	Urinary Inconti...	BioFeedback; Fu...	18 Years -	Azienda Ospedaliero Universitaria Maggiore della Carita

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