Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Weight Loss

Malnutrition

Body Weight

Duodenal Neoplasms

Body Weight Changes

Nutrition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

All Drugs and Chemicals

Gastrointestinal Agents

Antineoplastic Agents

Hormones

Glucagon

Somatostatin

Glucagon-Like Peptide 1

Octreotide

Antineoplastic Agents, Hormonal

Double-blind single dose octreotide-placebo crossover

Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen

Placebo

John V Reynolds, MCh, FRCS

Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery.

In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.

The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

University College Dublin

University of Dublin, Trinity College

Göteborg University

St. James's Hospital, Ireland

Surgical Research Fellow

Patients wear a Fitbit physical activity tracker daily, set physical activity goals, receive text messages, and view private social media peer support group content over 7-10 days once every 3 months. Patients also wear a research grade activity measuring device over 1-3 days and participate in a one-on-one interview once every 3 months for 9 months.

INTENSIVE PHASE: Patients wear a Fitbit physical activity tracker daily and receive weekly reminders to wear the Fitbit for 12 weeks. Patients attend weekly goal setting sessions, receive individualized physical activity goals, view and post private social media peer support group content 2-3 times weekly, and receive badges for 12 weeks.

MAINTENANCE PHASE: Patients wear a Fitbit physical activity tracker daily and set their own physical activity goals weekly for 4 weeks. Patients also receive access to the social media account and post content for 4 weeks.

Patients wear a Fitbit physical activity tracker daily for 12 weeks.

Goal Setting

Interview

View private social media peer support group content

Media Intervention

Medical Device Usage and Evaluation

Wear a research grade activity measuring device

Questionnaire Administration

Reward

Text Message-Based Navigation Intervention

Jason A Mendoza

This clinical trial tests the impact of a culturally-tailored home-based physical activity program on physical fitness in Hispanic or Latino/Latina adolescent and young adult (AYA) childhood cancer survivors. After treatment for cancer, some AYA survivors experience long-term effects from the cancer and its treatment including weight gain, fatigue and decreased physical fitness. Hispanic or Latino/Latina survivors may have a higher risk of these effects compared to non-Hispanics. Regular physical activity helps maintain healthy weight, energy levels and overall health. Participating in a culturally-tailored home-based physical activity program may help increase physical activity in Hispanic or Latino/Latina AYA childhood cancer survivors.

PRIMARY OBJECTIVES:

I. Use an iterative approach to develop a culturally-tailored multilevel remote-based physical activity (PA) intervention among 20 Latinx adolescent and young adult survivors of childhood cancer (AYA survivors), 10 whose preferred language is English and 10 whose preferred language is Spanish, using the StepByStep intervention as a starting point. (Stage 1) II. Conduct a randomized controlled trial (RCT) to test the potential efficacy of the culturally-tailored remote-based PA intervention (versus \[vs.\] Fitbit only) with respect to the primary outcome of moderate to vigorous physical activity (MVPA) measured with a research grade accelerometer over 12 weeks among a separate group of 170 Latinx AYA survivors whose preferred language is Spanish or English (n=85 per randomization arm) and who do not meet PA guidelines at baseline. (Stage 2)

SECONDARY OBJECTIVES:

I. Among the patients enrolled to the RCT component of the study, evaluate the potential efficacy of randomization to the intervention relative to control arm with respect to decreasing sedentary time as assessed by a research accelerometer.

II. Evaluate potential efficacy of randomization to the active intervention arm with respect to improvement in reported health-related quality of life.

EXPLORATORY OBJECTIVES:

I. Evaluate potential efficacy of randomization to the active intervention arm with respect to physiological measurements predictive of cardiometabolic health.

II. Determine the acceptability of and guidance on improving the intervention phases in preparation for a fully powered, long term RCT by conducting two rounds of post-trial qualitative interviews among selected consenting participants, n=30 for the intensive intervention phase and n=30 for the maintenance intervention phase.

OUTLINE:

STAGE 1: Patients wear a Fitbit physical activity tracker daily, set physical activity goals, receive text messages, and view private social media peer support group content over 7-10 days once every 3 months. Patients also wear a research grade activity measuring device over 1-3 days and participate in a one-on-one interview once every 3 months for 9 months.

STAGE 2: Patients are randomized to 1 of 2 groups.

GROUP I (INTERVENTION):

INTENSIVE PHASE: Patients wear a Fitbit physical activity tracker daily and receive weekly reminders to wear the Fitbit for 12 weeks. Patients attend weekly goal setting sessions, receive individualized physical activity goals, view and post private social media peer support group content 2-3 times weekly, and receive badges for 12 weeks.

MAINTENANCE PHASE: Patients wear a Fitbit physical activity tracker daily and set their own physical activity goals weekly for 4 weeks. Patients also receive access to the social media account and post content for 4 weeks.

GROUP II (CONTROL): Patients wear a Fitbit physical activity tracker daily for 12 weeks.

Investigators and participating site staff are blinded.

A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or Latino/Latina Adolescent and Young Adult Childhood Cancer Survivors, Walking Juntos Study

Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

Change in cardiopulmonary fitness will be measured using the 2-Minute Step Test and heart rate monitor.

Change in resting heart rate will be measured using the 2-Minute Step Test and heart rate monitor.

Estimates of intervention effects (mean differences) ascertained from linear mixed models (adjusted for stratification factors) will be presented along with associated confidence intervals and two-sided p-values.

P-values will be presented using both the nominal significance level of 0.05 and with adjustments for multiple comparisons using a false discovery rate methodology.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery	NCT02381249	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition Pancreatic Neop... Duodenal Neopla...	Octreotide Placebo	18 Years - 100 Years	St. James's Hospital, Ireland
A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or Latino/Latina Adolescent and Young Adult Childhood Cancer Survivors, Walking Juntos Study	NCT06410209	Hematopoietic a... Malignant Solid...	Goal Setting Interview Interview Media Intervent... Medical Device ... Medical Device ... Questionnaire A... Reward Text Message-Ba... Text Message-Ba...	15 Years - 21 Years	Children's Oncology Group
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery	NCT02381249	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition Pancreatic Neop... Duodenal Neopla...	Octreotide Placebo	18 Years - 100 Years	St. James's Hospital, Ireland

Spots Global Cancer Trial Database for reward

Every month we try and update this database with for reward 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 reward

Every month we try and update this database with for reward 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 reward 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.