Neoplasms

All Conditions

Mouth and Tooth Diseases

Carcinoma

Head and Neck Neoplasms

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Patients undergo ALTENS delivered via the Codetron machine QIW for 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo ALTENS delivered via the Codetron machine BIW for 12 weeks in the absence of disease progression or unacceptable toxicity.

Quality-of-Life Assessment

Transcutaneous Acupoint Electrical Stimulation

Anurag Singh

This randomized pilot clinical trial studies alternate schedules for acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia) caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is a procedure in which mild electric currents are applied to certain acupuncture points on the body and may help relieve dry mouth caused by RT and improve quality of life. It is not yet known whether giving ALTENS more frequently works better than standard ALTENS in treating dry mouth caused by RT.

PRIMARY OBJECTIVES:

I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS), compared to the standard ALTENAS schedule of twice-weekly for 12 weeks, at 15 months from the start of ALTENS treatment.

SECONDARY OBJECTIVES:

I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS), compared to the standard ALTENS schedule of twice-weekly for 12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment.

II. Examine the benefit of ALTENS treatment using a four-times weekly schedule for 6 weeks on overall quality of life, using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire, QLQ-C30, including the questionnaire module specific to head and neck cancers (QLQ-H\&N35), compared to the standard ALTENS schedule of twice-weekly for 12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment.

III. To compare the toxicity between treatment schedules using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo ALTENS delivered via the Codetron machine four times weekly (QIW) for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo ALTENS delivered via the Codetron machine twice-weekly (BIW) for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6, 9, 15, and 21 months.

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

Two Versus Four Times-Weekly ALTENS for Treatment of Radiation-Induced Xerostomia: A Pilot Study

A repeated measures model will be used to compare XeQoLS scores between the two arms at 15 months. Additional analysis will be performed using an area-under-the-curve (AUC) comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H\&N35 scores between the two groups over time.

A repeated measures model will be used to compare EORTC QLQ-C30 and the EORTC-QLQ-H\&N35 scores between the two arms. Additional analysis will be performed using an AUC comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H\&N35 scores between the two groups over time.

A repeated measures model will be used to compare XeQoLS scores between the two arms. Additional analysis will be performed using an AUC comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H\&N35 scores between the two groups over time.

The frequency of toxicities will be tabulated by grade.

Roswell Park Cancer Institute

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma, Squamous Cell

Laryngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Otorhinolaryngologic Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.

PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.

Photoacoustic Imaging

Anurag K Singh

This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.

PRIMARY OBJECTIVE:

I. Define the feasibility of the current photoacoustic imaging (PAI) technology in head and neck (H\&N) cancer patients.

SECONDARY OBJECTIVE:

I. Define the utility of the current PAI in H\&N cancer patients.

OUTLINE:

PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.

PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.

Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer

A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients

Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.

Descriptive statistics (means, medium) will be used to summarize percent of SO2

Compare hemoglobin measurements between baseline until end of study

National Cancer Institute (NCI)

Behaviors and Mental Disorders

Digestive System Diseases

Symptoms and General Pathology

Cognitive Dysfunction

Gastrointestinal Neoplasms

Postoperative Cognitive Complications

Digestive System Neoplasms

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Postoperative Complications

Gastrointestinal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Herbal and Botanical

Anesthetics

Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before anesthesia.

Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 30 min before anesthesia to the end of surgery

Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, once a day, 30 minutes each time for 7 consecutive days after operation

Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 1 day before operation to 7 days after operation, once a day, 30 minutes each time.

Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before the induction of anesthesia to the end of the surgery, 1 day before operation, and on the 1st, 2nd and 3rd days after surgery, 30 min once a day.

the electrodes were placed at the same time as the perioperative TEAS group, but the electronic stimulation was not applied and they were told that the TEAS treatment have no feeling

receive standardised perioperative management such as preoperative health education, optimize anaesthesia scheme, intraoperative heat preservation, and reduce surgical trauma.

Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.

Transcutaneous acupoint electrical stimulation

Daorong Wang Department Director, Ph.D

Liqun Shi

Postoperative cognitive dysfunction(POCD). is a central nervous system complication in cancer patients with a 8.9-46.1% incidence. It is mainly manifested as impaired memory, descending information handling ability and decline or damage of attention, perception, abstract thinking, executive, language, and body movement. However, it is difficult to identify and it can last for months or years or even become a dementia state, which can severely affect patients' postoperative recovery, prolong the hospitalization time, reduce the quality of life, increase the mortality and the consumption of family and social medical resources, and intensifies the national economic and social burden.

Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.

Also, studies have shown that TEAS treatment may improve the cognitive function of geriatric patients. Most studies have shown that TEAS treatment 10\~30 minutes before operation or from entering the operating room to the end of operation can reduce the incidence of POCD in elderly patients. Some studies showed that preoperative combined with postoperative or simple postoperative TEAS treatment can significantly improve patients' postoperative cognitive function. Our previous research showed that perioperative TEAS treatment can reduce the postoperative inflammatory response and increased the postoperative cognitive function score and decrease the incidence of POCD in geriatric patients with gastrointestinal tumor. Moreover, studies showed that long-term electroacupuncture treatment is easy to cause "tolerance effect', leading to the activation of the negative feedback mechanism of the body, and reduction of the number of receptors, and the weakening of the treatment effect. So, what is the best time period for TEAS to improve POCD and reduce the use of resources? Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.

Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.

Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients With Gastrointestinal Tumor

Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients With Gastrointestinal Tumor：a Protocol of Randomised Controlled Trial

Assess the cognitive function of the patient. The MMSE is a 30 points questionnaire used to measure orientation (time and place), memory (immediate and short term), attention, calculation, and language (naming, repetition, listening, reading, and writing) . Higher score means better cognitive function.

Assess the cognitive function of the patient. AVLT-H was used to evaluate the memory of the subjects.The subjects learned and recalled 12 words and repeated themself three times. After the nonverbal test interval of about 5min and 20min, the fourth (short delayed recall) and fifth (long delayed recall) repeat will be recorded respectively. The sixth recall was reconfirmation, that is, the data collectors read 24 words, and the subjects answered whether they had learned them. According to the knowledge level and cooperation degree of local elderly subjects, the fourth repeat will be recorded and a correct word will get 1 point.

Assess the cognitive function of the patient. DSC was used to evaluate the executive function of the subjects. For the test, the subjects need to fill in the numbers corresponding to the symbols within 90s. A correct number will get 1 point, up to 90 points.

Assess the cognitive function of the patient. VFT was used to evaluate the language ability of the subjects. The subjects should say as many names of animals, fruits and vegetables as possible within 1 minute. A correct object will get 1 point, no point will be given if repeated.

Assess the cognitive function of the patient. CDT was used to evaluate the visual spatial structure ability of the subjects. The subjects need to draw the dial of the clock on paper and write the numbers in the correct position. Scoring method: ① Draw a closed circular outline, 1 point. ②The number display and sequence in the dial are correct, 2 points. ③The position of the hour and minute hand is correct, 1 point. To reduce the learning effect, the test time preoperative and postoperative in this study is drawn at 08:10 and 07:50 respectively.

Evaluate patients' postoperative inflammatory status. IL-6 is a pro-inflammatory cytokine which can mediate inflammatory and immune responses in the CNS.

Evaluate patients' postoperative inflammatory status. S100β is a biomarker which existed in the cell of peripheral and central nervous system(CNS) and it may participate in the mechanism of cognitive impairment.

Evaluate patients' postoperative inflammatory status. As one of the neurotrophic factors, IGF-1 has been proved to have neuroprotective and neuroproliferative effects and it may delay the degeneration of dopaminergic neurons, protect dopaminergic neurons and promote nerve regeneration through a variety of ways, including inhibiting inflammatory reaction. IGF-1 plays an important role in the survival and differentiation of neurons, and is related to a variety of neurodegenerative diseases. Studies showed that the level of serum IGF-1 in patients with Parkinson's disease(PD) is related to cognitive dysfunction, and serum IGF-1 may be a biomarker of cognitive dysfunction in patients with PD.

Evaluate patients' postoperative inflammatory status. CRP is a non-specific biomarker inflammation which has been proved to accelerate the development of neurodegenerative disorders by activating microglia, increasing levels of proinflammatory cytokines, and activating the complement cascade.

Evaluate the postoperative recovery of patients. On the scale of the 10 point system, the self rating is based on the degree, which is divided into 1-10 levels. According to the corresponding numbers, the pain can be divided into different degrees, that is, level 0 means no pain, level 1-3 means mild pain, level 4-6 means moderate pain, and level 7-10 means severe pain.

Branden is divided into six dimensions: perception, humidity, activity mode, activity ability, nutrition, friction and shear force. The friction and shear force are rated at Level 3, and the rest are rated at level 4, with a score range of 6-23 points. The higher the score, the smaller the risk of pressure ulcer occurrence, with 15-18 points for mild risk, 13-14 points for moderate risk, 10-12 points for high risk, and ≤ 9 points for serious risk.

BI is a tool widely used in clinic to evaluate patients'activities of daily living(ADL). It includes 10 items, including diet, bed and wheelchair transfer, personal hygiene, toileting, bathing, walking, going up and down stairs, dressing, defecation control and urination control, with a total score of 100 points. If the score is in the range of 0 \~ 40 points, it belongs to severe ADL deficiency; if it is in the range of 41 \~ 60 points, it belongs to moderate ADL deficiency; if it is in the range of 61 \~ 100 points, it belongs to mild ADL deficiency. The BI scale can be evaluated by asking patients or their families, which is simple, fast and highly reliability.

Assess the cognitive function of the patient. TICS-m is modified from the earliest version of TICS which is modeled on MMSE. Gallo and Breitiner revised the original version, adding tests such as delayed memory of words and five times of phone tapping, and expanded it to 21 items, with a total score of 50 points. It can be divided into three parts: memory (20 points), orientation (13 points), language and attention (17 points). The higher the score, the better the condition of the project. \<28 points is defined as dementia, 28\~32 points is defined as mild cognitive impairment(MCI). More over the TICS-m has been proved to have good reliability and validity in the Chinese population.

Record the first anal exhaust time after operation

Record the first defecation time after operation

Record the first eating time after operation

Record the time of get out of bed for the first time after operation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer	NCT02474095	Head and Neck C... Xerostomia	Quality-of-Life... Transcutaneous ...	18 Years -	Roswell Park Cancer Institute
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer	NCT04110249	Head and Neck C... Head and Neck L... Head and Neck S... Laryngeal Neopl... Radiation Thera...	Photoacoustic I... Transcutaneous ...	18 Years -	Roswell Park Cancer Institute
Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients With Gastrointestinal Tumor	NCT05482477	Postoperative C...	Transcutaneous ...	60 Years -	Subei People's Hospital of Jiangsu Province
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer	NCT04110249	Head and Neck C... Head and Neck L... Head and Neck S... Laryngeal Neopl... Radiation Thera...	Photoacoustic I... Transcutaneous ...	18 Years -	Roswell Park Cancer Institute
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer	NCT02474095	Head and Neck C... Xerostomia	Quality-of-Life... Transcutaneous ...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for transcutaneous acupoint electrical stimulation