Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Behaviors and Mental Disorders

Head and Neck Neoplasms

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Quality of Life

Swallowing Exercises

Kenneth Jensen, MD

Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis: Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the tolerated intensity of exercises and establish the method of measuring training intensity and dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing and HN pain endpoint of EORTC H\&N35 questionnaire. Weight loss, duration of tube feeding.

Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

University of Aarhus

MD ph.d.

Gland and Hormone Related Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Pancreatic Neoplasms

Body Weight

Weight Loss

Wasting Syndrome

Cachexia

Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Pancreatic Cancer

The peptide-based formula (Peptamen) will be administered through a gastrojejunal or jejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered for three 28-day cycles.

Jejunal or gastrojejunal tube feeds will be given as continuous feeds via pump with Peptamen (medical food), at the patient's home, for the duration of the protocol and as directed by the nutritionist.

Tube feeding

Andrew Hendifar, MD

Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. Patients must be greater than 18 years of age; and have greater than 3 months life expectancy.

This study will observe a standard of care intervention (tube feeding) for potential benefit. Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the duration of the protocol.

In this study, we will prospectively evaluate advanced pancreatic adenocarcinoma patients with cachexia, who are receiving enteral feeding, with a peptide based diet (medical food), through a jejunal or gastrojejunal feeding tube. We plan to collect serum samples routinely and establish a cohort of patients with this clinical syndrome. Our aims are to establish the feasibility and efficacy of enteral nutrition and its relationship to meaningful clinical outcomes. Furthermore, we will assess for a correlation between cachexia, activity, and patient reported outcomes on domains of quality of life in an optional activity tracker sub-study.

Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding

Assessment based on tumor biomarkers during enteral feeding period

As measured by stool sample microbiome analysis

Assistant Professor of Medicine

Esophageal Neoplasms

Esophageal Cancer

Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively.

Tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at post-op day #8, or upon discharge,

Tube Feeding

Philip W Carrott, MD

Patients undergoing an esophagectomy will be randomized to receive either (1) routine post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at POD#8, or upon discharge.

Specific Aim 1 is to determine the occurrence of common complications and readmissions post-operatively between the two patient groups. The investigators hypothesize that routine use of tube feeding may reduce the occurrence of post-operative complications.

Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects recovery and QOL after esophagectomy. The investigators hypothesize that routine post-operative supplementation will enhance patients recovery and QOL.

For esophagectomy specifically, there is very limited literature evaluating the complication rate and QOL associated with the length of post-operative tube feeding and adequate nutritional requirements. Small randomized studies have not shown a benefit to routine tube feeding, although the numbers were very small, ranging from 12-70 per group. The investigators will randomize 200 patients for the purpose of this study.

Routine Post-Operative Supplemental Nutrition

Routine Post-Operative Supplemental Nutrition: A Randomized Controlled Trial

atrial fibrillation, delirium, anastomotic leak, and pneumonia

Quality of Life will be assessed using the EORTC QLQ-30 Survey Instrument. Post-operative QOL assessment will be compared to baseline (prior to surgery) QOL assessment.

j-tube specific complications include infection, bowel obstruction that may require surgical repair, discomfort, diarrhea and dumping syndrome

University of Michigan

Assistant Professor of Thoracic Surgery, Medical School

Totally 42 cancer patients with poor nutritional status under nasogastric (NG) tube feeding was recruited and administered with the commercial nutritional formula (PCNF; 237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks (84 days).

PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks

Protison cancer nutritional formula (PCNF)

Chin-Kun Wang, Ph.D

Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, oncologic nutritionist strongly recommends cancer patients (with cachexia) to consume a diet rich in protein and dietary fibers along with balanced essential micronutrients like vitamins and minerals (Van Norren et al., 2009; Yeh et al., 2013). From the above statement, it cleared that nutritional support is a crucial aspect of multi-modal cancer care, by improving the overall health status by suppressing various adverse events as well as enhance treatment regimen for a speedy recovery. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

Supplementation with the commercial nutritional formula (PCNF; 237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks

Effect of Nutritional Formula (Protison) on Various Cancer Patients: A Randomized Clinical Trial

Role of Ready to Drink Nutritional Formula (Protison Enriched With ω-3 FA and BCAA) Supplemented by Nasogastric Tube Feeding in Various Cancer Patients: A Randomized Clinical Trial

The mean value of calorie intake (energy) were significantly increased in PCNF supplemented subjects

BMI were markedly improved in PCNF intook subjects

Protein nutritional assessment index (total protein, pre-albumin , and transferrin) were significantly improved

No significant changes in any of the glycemic indices or lipid profile PCNF groups

Chung Shan Medical University

Professor

Constipation

Signs and Symptoms, Digestive

Gastrointestinal Agents

All Drugs and Chemicals

Bismuth subsalicylate

This group will receive tube feeding formula that contains fiber.

This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.

Fiber containing tube feeding formula

Lisa M Epp, BS

Yolanda I Garces, MD

During radiation treatment for head and neck cancer a large percentage of patients at Mayo Clinic Rochester develop the need for tube feeding to meet nutrition and hydration needs. These patients are usually taking pain medication along with a stool softener or laxative. Currently, when these patients get a feeding tube it is our standard practice to choose a fiber-free enteral tube feeding formula as to not worsen their constipation. Currently, there are no guidelines as to which patients are good candidates for fiber containing enteral tube feeding formulas. The investigators hope this study will help determine if fiber containing enteral tube feeding formulas can be used for patients undergoing radiation for head and neck cancer without increasing rates of constipation or increasing use of stool softeners/laxatives.

Hypothesis: Participants enrolled in the study will not have increased rates of constipation on fiber-containing enteral tube feeding formula compared to historical standards on fiber-free formula.

Fiber Formula Study Among Radiation Oncology Patients

Pilot Study: "Does Using a Fiber Containing Enteral Tube Feeding Formula Increase Constipation and the Use of Stool Softeners in Patients Undergoing Radiation Therapy and Have a Percutaneous Endoscopic Gastrostomy (PEG) Placed?"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy	NCT00332865	Head and Neck C...	Swallowing Exer...	18 Years -	University of Aarhus
Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients	NCT02400398	Pancreatic Neop... Pancreatic Canc... Cachexia Weight Loss	Tube feeding	18 Years -	Cedars-Sinai Medical Center
Routine Post-Operative Supplemental Nutrition	NCT02297607	Esophageal Canc...	Tube Feeding	18 Years - 99 Years	University of Michigan
Effect of Nutritional Formula (Protison) on Various Cancer Patients: A Randomized Clinical Trial	NCT04643613	Cancer	Protison cancer...	55 Years - 84 Years	Chung Shan Medical University
Effect of Nutritional Formula (Protison) on Various Cancer Patients: A Randomized Clinical Trial	NCT04643613	Cancer	Protison cancer...	55 Years - 84 Years	Chung Shan Medical University
Fiber Formula Study Among Radiation Oncology Patients	NCT00888147	Constipation	Fiber containin...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for tube feeding

Every month we try and update this database with for tube feeding 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.