Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Usual Care. Participants in this arm will receive Usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test, however no further outcomes will be assessed. Thus, during the course of the study, all participants in this arm will have solely received usual care.

Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.

Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.

Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.

Letter Only

Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.

Letter and Educational DVD

Kenzie Cameron, PhD

The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.

Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening

Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-study 2

What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.

This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.

Agency for Healthcare Research and Quality (AHRQ)

Northwestern University

Research Associate Professor

Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.

Usual Care

Behavioral: Letter Only

Behavioral: Letter and Educational DVD

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Early termination prior to collection of primary or secondary outcome measures, hence no analyses of the primary or secondary outcomes were performed.Thus, the only results reported are baseline characteristics of enrolled participants.

Kenzie A. Cameron, PhD, MPH

Please note that no analyses were performed as the trial was stopped due to low enrollment.

Usual Care - participants receive usual care

Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.

Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.

The Secondary Outcome for the Study is the Time to Screening Completion.

Completion of CRC Screening

Overall Study

Herbal and Botanical

All Drugs and Chemicals

Common Bean

Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days.

Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days.

Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days.

Placebo-Control Meals and Snacks

Cooked Navy Bean Powder Meals and Snacks

Rice Bran Meals and Snacks

Elizabeth P Ryan, PhD

The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.

Objectives:

1. To learn about how increased cooked navy bean powders or rice bran dietary intake affect the stool microbiota of colorectal cancer survivors and healthy adults.
2. To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
3. To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.

Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial

National Cancer Institute (NCI)

Poudre Valley Health System

Colorado State University

Assistant Professor of Toxicology and Nutrition

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nausea

Vomiting

Genital Neoplasms, Female

Signs and Symptoms, Digestive

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Palonosetron

Fosaprepitant

Aprepitant

Cisplatin

Dexamethasone acetate

Serotonin

Substance P

Neurokinin A

Serotonin Receptor Agonists

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.

Fosaprepitant dimeglumine

Placebo

Jorn Herrstedt, MD, DMSci

Christina Ruhlmann, MD

Dorothy Keefe, MD, FRACP

Petra Feyer, MD, DMSci

Thomas Broe Christensen, MD, PhD

Gunnar Kristensen, MD, PhD

Henrik Roed, MD, DMSci

Felix Hilpert, MD, DMSci

Jacob C Lindegaard, MD

GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.

The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.

Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin

A Multinational, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Tolerability of Palonosetron and Dexamethasone Plus Fosaprepitant or Placebo in Patients Receiving Radiotherapy and Weekly Cisplatin.

Helsinn Healthcare SA

Odense University Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Esophagitis

Esophageal Diseases

Gastroenteritis

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Anti-Infective Agents

Pharmaceutical Solutions

Neuroprotective Agents

Antirheumatic Agents

Analgesics

Flavonoid

Lidocaine

Anesthetics

Anti-Bacterial Agents

Anesthetics, Local

Antibiotics, Antitubercular

Epigallocatechin gallate

Gentamicins

Clotrimazole

Miconazole

Anti-Inflammatory Agents, Non-Steroidal

Antifungal Agents

Narcotics

Antioxidants

Protective Agents

Epigallocatechin

EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed. Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4.

EGCG

EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.

mLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day. Patients were given oral mLDG solution, and began medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.

mLDG

Ligang Xing, MD,PhD

The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy. In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.

Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy

Shandong Cancer Hospital and Institute

Principal Investigator

Skin and Connective Tissue Diseases

Dermatitis

Breast Neoplasms

Skin Diseases

Breast Diseases

EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution;The solution is sprayed three times a day at 0.05 ml/cm2 to the whole radiation field until two weeks after radiation completion; Patients who developed grade Ⅱ radiation-induced dermatitis have the option to either withdraw from the study or to continue with EGCG. Patients are follow general good skin care practices during radiation therapy, such as not applying water soaks to relieve itching or pain, not vigorously rubbing the irradiated area, or not erasing ink marks; patting the skin dry with a soft towel; avoiding exposure to the sun; and wearing loose and cotton clothes. They are advised not to use deodorant, lotion, cream, make up, perfume or any other product on the area during the course of radiation therapy.

The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group.

placebo

The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.

Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy

Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening	NCT00860249	Colorectal Canc...	Letter Only Letter and Educ...	50 Years - 50 Years	Northwestern University
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial	NCT01929122	Colorectal Canc...	Placebo-Control... Cooked Navy Bea... Rice Bran Meals...	18 Years -	Colorado State University
Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin	NCT01074697	Nausea Vomiting Genital Neoplas...	Fosaprepitant d... Placebo	18 Years -	Odense University Hospital
Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy	NCT02577393	Lung Neoplasms Esophagitis Prevention & Co... Epigallocatechi...	EGCG EGCG mLDG	18 Years -	Shandong Cancer Hospital and Institute
Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening	NCT00860249	Colorectal Canc...	Letter Only Letter and Educ...	50 Years - 50 Years	Northwestern University
Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy	NCT02580279	Breast Neoplasm... Dermatitis Prevention & Co... Epigallocatechi...	EGCG placebo	18 Years - 70 Years	Shandong Cancer Hospital and Institute
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial	NCT01929122	Colorectal Canc...	Placebo-Control... Cooked Navy Bea... Rice Bran Meals...	18 Years -	Colorado State University
Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy	NCT02580279	Breast Neoplasm... Dermatitis Prevention & Co... Epigallocatechi...	EGCG placebo	18 Years - 70 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for prevention & control