Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Depression

Depressive Disorder

Depressive Disorder, Major

Depressive Disorder, Treatment-Resistant

Ganglion Cysts

Synovial Cyst

Cysts

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Bupivacaine

Anesthetics

Anesthetics, Local

Injection of Bupivacaine Hydrochloride 0.5% near the stellate ganglion.

Injection of Normal Saline near the stellate ganglion

Injection of Bupivacaine near the stellate ganglion

Bupivacaine Hydrochloride

Normal Saline

Karim Ladha, MD

This is a feasibility study, to investigate a new treatment option for major depressive disorders by performing a Stellate Ganglion Block (SGB). A SGB is an injection of local anesthetic into the sympathetic nervous system (peripheral nervous system) located in the lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.

Stellate Ganglion Block for Major Depressive Disorder.

Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial

No individual participant data has been planned to be shared with other researchers at this point since this is a feasibility study with only 10 participants.

Recruitment rate, withdrawal rate, adherence rate, frequency of adverse events

≥ 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score. The MADRS score range from 0 to 6 = no depression; from 7 to 19 = mild depression, 20 to 34 = moderate depression, 35 and greater = severe depression, and a total score of 60 or greater = very severe depression

Unity Health Toronto

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Shinichi Yachida, M. D. Ph. D.

Yasuyuki Suzuki, M. D. Ph. D.

Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.

Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with S-1 has been the standard treatment for stage II/III gastric cancer. However, for far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally far-advanced gastric cancer. However, previous studies of NAC have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control.

On the other hand, other studies have reported that anticancer drugs, including S-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.

Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer

Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion

Kagawa University

Tatsushi Inoue

Hematinics

Liver Extracts

Participants randomised to the self-acupuncture arm will be asked to attend a group workshop. All participants will be taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36. If deemed to be clinically appropriate by the acupuncturists, and if patients are willing and able, they will also be taught how to safely needle the acupuncture points Spleen 6 and/or Liver 3 (maximum of six points in total). Participants will be asked to needle the points 2-3 times a week throughout their cancer treatment and for 3 months post treatment.

Chemotherapy patients allocated to standard care will receive no additional treatments. 'Standard care' for all patients will be consistent with current best practice.

Participants be taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36. If deemed to be clinically appropriate by the acupuncturists, and if patients are willing and able, they will also be taught how to safely needle the acupuncture points Spleen 6 and/or Liver 3 (maximum of six points in total).

Self-acupuncture

John Hughes

The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering self-acupuncture within an NHS cancer care setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of teaching cancer patients to self-administer acupuncture to alleviate symptoms of cancer and the side effects of conventional chemotherapy treatment. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1) self-acupuncture in addition to standard care or 2) standard care alone. Participants randomised to the self-acupuncture arm will be asked to attend a 1.5 hour group workshop delivered by an experienced practitioners and teachers of self-acupuncture. Participants allocated to standard care will be offered training in self-acupuncture once the trial is complete to address any ongoing side effects from their cancer and its treatment. Patients will be recruited at the initiation of their chemotherapy cancer treatment from UCH Macmillan Cancer Centre. Participants will complete baseline outcome measures and be asked to complete follow up outcomes measures at the end of chemotherapy treatment, and 3 months post chemotherapy treatment. At the end of chemotherapy treatment participants will also be asked to take part in a qualitative telephone interview to explore their views on the design of the study and if allocated to self-acupuncture their views on the intervention. At 3 months post chemotherapy treatment those allocated to self-acupuncture will be invited to participate in a second qualitative interview to explore the long-term practice and effects of self-acupuncture. Qualitative interviews will also be conducted with stakeholders (acupuncturists delivering workshops and UCH Macmillan Cancer Centre staff) to explore their views on the feasibility of teaching cancer patients self-acupuncture.

Feasibility Trial Self-Acupuncture for Chemotherapy Cancer Patients

A Feasibility Trial of Self-Acupuncture for Chemotherapy Cancer Patients (SACC Trial)

This is a well-validated quality of life questionnaire focusing on functional assessment. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.

The MFI is a well-validated scale measuring general fatigue including the dimensions of physical and mental fatigue, activity, and motivation. The questionnaire comprises 20 items for which the person must specify the extent to which the particular statements relates to them on a five-point scale, ranging from Yes, that is true to No, that is not true.

This is a multidimensional scale which evaluates 32 physical and psychological symptoms associated with cancer and its treatment.

The Visual Analogue Scale (VAS) is a commonly used outcome measurement to monitor variations in patient reported quality of life.

University College London Hospitals

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Breast Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.

The intervention will be based on a remote approach, lasting 12 weeks. The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week. The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.

Home based exercise training

Daniel Umpierre de Moraes, PhD

Larissa Xavier Neves da Silva, Master

Larissa Xavier Neves da Silva, MSc

The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.

This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach.

The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.

This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.

The trial is designed for female breast cancer patients and male prostate cancer patients.

Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)

Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)

Files will be as de-identified as possible before public data sharing. After data protection and data handling routines, de-identified data will be readily available to all project contributors. We consider research data gathered from data collection from research participants pertains primarily to these individuals. Therefore, all individual data will be available to their owners throughout the project. Structured data that will result from this research project will pertain to the PI (Daniel Umpierre), who will be responsible for data integrity, and to the institution (Hospital de Clinicas de Porto Alegre).

The specific structure for data sharing as well as plataforms are still to be defined. As soon, we define the remaining details of our data sharing strategy the IPD plan will be updated.

Fatigue scores using specific questionnaires of Functional Assessment of Cancer Therapy (FACT questionnaire) for breast or prostate cancer patients.

Quality of life scores using specific questionnaires of FACT (Functional Assessment of Cancer Therapy) for breast or prostate cancer patients.

Total distance (in meters) performed during the six minute walk test.

Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.

Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape.

Physical activity calculated in minutes and intensity per week, of physical activity using the International Physical Activity Questionnaire (IPAQ).

Through the development of the study, participants will be asked to engage in a focal group to discuss outcomes relevant to be assessed in trials with exercise interventions targeted for patients with breast or prostate cancer.

Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.

Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility.

Self-reported adverse events, related or not to the study. These measures will be mostly received by phone calls or text messaging.

Hospital de Clinicas de Porto Alegre

Nervous System Diseases

Chronobiology Disorders

Single arm study receiving a multi-modal intervention

A psychoeducational and evidence-based skills and strategies course for insomnia delivered online over four lessons through ThisWayUp. This will be completed during an 8-week feasibility trial.

Cognitive behavioural therapy for Insomnia (CBT-I)

Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial.

Bright Light Therapy

An individualised activity plan is created at baseline and adjusted weekly aiming to increased daytime physical activity and reduce sedentary behaviours. The activity plan takes into consideration personal interests, perceived barriers to activity and develops an activity plan using Specific Measureable Achievable Realistic and Timely (SMART) goals. This will take place during an 8-week feasibility trial.

Individualised activity plan

Two clinical reviews will take place during an 8-week feasibility trial and consider uncontrolled symptoms, medication and blood test abnormalities which may impact on rest and physical activity levels

Clincial review

Craig Gouldthorpe

Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.

A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)

The RALI Study: a Multimodal Non-pharmacological (Clinical Review, Physical Activity, Bright Light Therapy and Cognitive Behavioural Therapy for Insomnia) Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Patients With Advanced Cancer

Patient completed questionnaire of the acceptability and usability of interventions and research assessments

Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher

Number of subjects develop adverse events during the trial in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

Number of participants completing the midpoint and end of study assessments

Number of participants recruited to the feasibility study over a 1 year period

Memorial Symptom Assessment Score Short Form (MSAS-SF). The scale assesses the presence and level of distress (Not at all, A little bit, Somewhat, Quite a bit, Very much) associated with 32 physical and psychological symptoms. Higher scores suggest increased symptomatology and increased distress

European Organisation for Research and Treatment of Cancer QLQ-C30. Participants rate 28 symptom and quality of life measures on a scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Higher scores suggest a worser outcome. Participants also rate their overall health and quality of life on a scale 1-7 (1 = very poor, 7 = excellent).

Epworth Sleepiness Scale. Participants rate the likelihood of falling asleep in 8 scenarios. Higher scores suggest increased daytime sleepiness

Brief Pittsburgh Sleep Quality Index (bPSQI). Participants complete 6 questions with higher scores suggesting poorer sleep quality.

Physical activity will be captured over a continuous 72-hour period using wrist and thigh accelerometry. Accelerometry devices collect activity counts during 1 minute periods (epochs).

A novel diary will be completed. Daytime physical activity will be assessed (level of tiredness, level of exertion, time spent during different activity intensities). Additional medication, smoking, caffeine and alcohol use will be documented. Nighttime sleep will also be assessed (time in bed, time to lights off, time to fall asleep, waking time, out of bed time, sleep quality).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stellate Ganglion Block for Major Depressive Disorder.	NCT04727229	Treatment Resis... Major Depressiv...	Bupivacaine Hyd... Normal Saline	18 Years - 65 Years	Unity Health Toronto
Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer	NCT01381913	Gastric Cancer Chemoradiation		20 Years - 80 Years	Kagawa University
Stellate Ganglion Block for Major Depressive Disorder.	NCT04727229	Treatment Resis... Major Depressiv...	Bupivacaine Hyd... Normal Saline	18 Years - 65 Years	Unity Health Toronto
Feasibility Trial Self-Acupuncture for Chemotherapy Cancer Patients	NCT05929690	Cancer	Self-acupunctur...	16 Years -	University College London Hospitals
Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)	NCT05258526	Breast Cancer Prostate Cancer	Home based exer...	18 Years -	Hospital de Clinicas de Porto Alegre
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)	NCT06329479	Circadian Rhyth... Cancer	Cognitive behav... Bright Light Th... Individualised ... Clincial review	18 Years -	University of Dublin, Trinity College
Feasibility Trial Self-Acupuncture for Chemotherapy Cancer Patients	NCT05929690	Cancer	Self-acupunctur...	16 Years -	University College London Hospitals
Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer	NCT01381913	Gastric Cancer Chemoradiation		20 Years - 80 Years	Kagawa University

Spots Global Cancer Trial Database for feasibility trial