Digestive System Diseases

All Conditions

Neoplasms

Colonic Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Laxatives

Cathartics

The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.

The control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet.

Laxative 4 liters polyethylene glycol 4000 in split fashion.

Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days

Low-residue diet

Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet

Usual care

Marco Antonio Alvarez González, MD, PhD

This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.

There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability.

All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study

The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation

Ratio of successful cecal intubations in each study arm

Ratio of polyps and adenomas detected in each study arm

Each participant will rate his/her experience in an analogue visual scale

Description of all spontaneously reported adverse events.

Each participant will rate his/her experience in a questionnaire.

Parc de Salut Mar

Blood and Lymph Conditions

Rare Diseases

Neutropenia

Granulocytopenia

Oculocerebral Syndrome With Hypopigmentation

Lenograstim

Adjuvants, Immunologic

Immunologic Factors

patients were administered pegylated filgrastim 100 ug/kg in cycle 1 and ﬁlgrastim 5 ug/kg/d in cycle 2

patients received ﬁlgrastim 5 ug/kg/d in cycle 1 and pegylated filgrastim 100 ug/kg in cycle 2

pegylated filgrastim and ﬁlgrastim

ﬁlgrastim and pegylated filgrastim

Yuankai Shi, M.D.

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and delay the schedule of chemotherapy. Preventive filgrastim administration has long been established as the standard of care. A pegylated filgrastim was independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with ﬁlgrastim. These characters were similar to those of Neulasta.

The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare the efficacy and safety of a single injection of pegylated filgrastim and daily injections of ﬁlgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis is that pegylated filgrastim is similarly effective and safe with regular filgrastim.

This was a multicenter, randomized, open-label, cross-over, noninferiority study to evaluate whether a single injection of pegﬁlgrastim is as effective and safe as daily injections of ﬁlgrastim in patients receiving commonly used chemotherapy regimens. Patients were randomly assigned in a 1:1 ratio to AOB and BOA arm with center as the stratiﬁcation variables. All the patients received two cycles of chemotherapy of identical regimen and dosage. In arm AOB, patients were administered pegylated filgrastim 100 ug/kg in cycle 1 and ﬁlgrastim 5 ug/kg/d in cycle 2; while in arm BOA, patients received ﬁlgrastim 5 ug/kg/d in cycle 1 and pegylated filgrastim 100 ug/kg in cycle 2.

Study drugs Both filgrastim and pegylated filgrastim were provided by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China.

In cycle 1 of AOB arm and cycle 2 of BOA arm, on 9 am of day 3, patients were to receive a dose of 100µg/kg of pegylated filgrastim, based on actual body weight, as a single s.c. injection.

In cycle 2 of AOB arm and cycle 1 of BOA arm, patients were to receive daily s.c. injection of filgrastim at a dose of 5 µg/kg/day. Injections began on 9 am of day 3 and continued daily until an absolute neutrophil count (ANC) ≥10.0 × 109 /l was documented after the expected nadir or for a maximum of 14 days, whichever occurred first.

Chemotherapy Treatment All cytotoxic agents were administrated on day 1 of the 21-day regimens. The regimens include PC(paclitaxel 175 mg/m2; carboplatin area under curve\[AUC\] 5～6 or cisplatin 75 mg/m2 )； AC (doxorubicin \[or pirarubicin\]60 mg/m2 or epirubicin 100 mg/m2；cyclophosphamide 600 mg/m2), PA(paclitaxel 175 mg/m2 ；doxorubicin \[or pirarubicin\]50 mg/m2 or epirubicin 80 mg/m2）； CHOP (cyclophosphamide 750mg/m2；doxorubicin\[or pirarubicin\] 50 mg/m2 or epirubicin100 mg/m2；vincristine1.4 mg/m2；prednisone 100mg，po，day 1-5)。 Efficacy measurements Blood samples were collected for complete blood counts (cbc) with differential on days 0, 3, 5, 7, 9, 11, 13, 17 and 21 of each cycle. Day 0 was defined as the day before day one, in cycle 1 it is the base line, and in cycle 2 is day 21 of cycle 1.

The primary efficacy end point was protective rate of grade 4 neutropenia after chemotherapy (defined as the rate of ANC keeps above 0.5 × 109 /l through the whole cycle). The secondary efficacy end points included the rate of grade 3/4 neutropenia, time to neutrophil recovery (deﬁned as the time from chemotherapy administration until the patient's ANC increased to 2.0 × 109/l after the expected nadir), incidence of febrile neutropenia (defined as ANC\<0.5×109/L and auxiliary temperature\>38.0℃), incidence of antibiotic administration and ANC profile.

Safety assessments Patients recorded their auxiliary temperature daily, and were monitored for adverse events throughout the study. Before chemotherapy and in the third week of each chemotherapy cycle, serum hepatic and renal function, electrolysis, urine routine test and electrocardiograph were examined.

The safety endpoint of this study was incidence and severity of adverse events (WHO grade 1-4), side effects, and changes in clinical laboratory values.

A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy

A Multicenter, Randomized, Cross-over Phase 3 Comparing Preventive Pegylated Filgrastim and Filgrastim in Cancer Patients Receiving Myelosuppressive Chemotherapy

the rate of ANC keeps above 0.5 × 109 /l through the whole cycle

the time from chemotherapy administration until the patient's ANC increased to 2.0 × 109/l after the expected nadir

expected and untoward events caused by study drug or control drug

rate of ANC\<0.5×109/L and auxiliary temperature\>38.0℃

Fujian Cancer Hospital

Beijing Chest Hospital

Hospital affiliated to Academy of Military Medical Sciences

Tianjin Medical University Cancer

Fudan University

First Hospital of China Medical University

Hunan Cancer Hospital

West China Hospital

The Second Affiliated Hospital of Dalian Medical University

Peking University Third Hospital

Tianjin People's Hospital

Qilu Hospital of Shandong University

Zhejiang Cancer Hospital

Changhai Hospital

Chinese Academy of Medical Sciences

Dr. Yuankai Shi

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Micronutrients

Vitamins

Ascorbic Acid

Bisacodyl

Vitamin C

1 L of PEG containing ascorbic acid (PEG A) was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure. All colonoscopies were performed between 9 am and 1 pm.

10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.

Polyethylene Glycols

Yoon Tae Jeen

Seung Hun Kang

Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg) formulation to determine the quality of bowel cleansing and patient tolerability.

- Study design A single center, randomized, comparative observer-blinded study was performed from May 2015 to September 2015 at the Department of Gastroenterology and Digestive Endoscopy at Korea University Anam Hospital (Seoul, Korea).

In total, 200 outpatients received lower volume 1-L PEG with ascorbic acid plus bisacodyl (1L-PEG/AB) or low volume 2-L PEG with ascorbic acid (2L-PEG/A) in a 1:1 ratio.

At the time of registration, subjects were randomly allocated to either group. They were randomized by a computer-generated list and were provided with written instructions. All patients provided written informed consent.

* Patients All patients between the ages of 20 and 75 years. Patients were excluded from the analysis if they had known or suspected gastrointestinal obstruction, Ileus, severe heart failure, uncontrolled hypertension (systolic pressure \> 170 mmHg, diastolic pressure \> 100 mmHg), severe constipation, clinically significant electrolyte abnormalities, any prior bowel resection, or significant gastroparesis.
* Bowel preparation In the 2L-PEG/A group, 1 L of PEG containing ascorbic acid was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure.

The 1L-PEG/AB group received 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.

- Assessment by endoscopists Colonoscopies were performed by two expert endoscopists who were blinded to the preparation regimen. These two endoscopists worked for more than 5 years at our institution.

Bowel cleansing was scored by the same endoscopist performing the colonoscopy. To assess the cleansing quality of the bowel preparations, the Boston Bowel Preparation Scale (BBPS) and the Aronchick Bowel Preparation Scale (ABPS) were used.

- Assessment of patient tolerability and adverse events Before the colonoscopy procedure, patients completed questionnaires about their symptoms associated with the preparations to assess tolerability. Patients were asked to assess the degree of abdominal fullness, abdominal pain, nausea, vomiting, sleep disturbances, and general discomfort using a 5-point scale (i.e., none, mild, moderate, severe, or very severe).

The palatability of the preparation was graded in 5 categories: very good, good, acceptable, disgusting, and bad.

- Sample size and statistical analysis A sample size of at least 89 patients group was required for each treatment group to detect a difference in treatment success of a 5% type-I error rate and 80% power for a two-tailed χ2 test. Our sample size was based on the results from a pilot study that was conducted in our hospital and included 35 patients in each group. It was estimated that the efficacy for excellent treatment success would be 49% with PEG-2L/A and 30% with PEG-1L/AB. Based on these data, we decided to collect 100 patients per treatment group for study.

Continuous variables were expressed as mean ± standard deviation (SD), and discontinuous variables were expressed as counts and percentages. SPSS 20.0 for Windows (SPSS Inc., Chicago, IL, US) was used for data entry and statistical analyses. For the analyses between the two treatment groups, Students t-test as appropriate was used to compare continuous variables and either the Chi-square or Fisher's exact test were used for categorical data. The p-values \< 0.05 were considered statistically significant.

Comparison of Low Volume PEG-Asc and Lower Volume PEG-Asc With Bisacodyl

Comparison of a Split Dose Bowel Preparation With 2-L Polyethylene Glycol Plus Ascorbic Acid and 1-L Polyethylene Glycol Plus Ascorbic Acid and Bisacodyl Prior to Colonoscopy

Patients were asked with questionnaires about the symptoms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Low-fiber Diet for Colorectal Cancer Screening Colonoscopy	NCT02401802	Colonic Disease...	Low-residue die... Usual care	18 Years -	Parc de Salut Mar
A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy	NCT01285219	Cancer	pegylated filgr... ﬁlgrastim and p...	18 Years - 70 Years	ChineseAMS
Comparison of Low Volume PEG-Asc and Lower Volume PEG-Asc With Bisacodyl	NCT02980562	Bowel Disease Colon Adenoma	Polyethylene Gl... Bisacodyl	20 Years - 75 Years	Korea University Anam Hospital
Comparison of Low Volume PEG-Asc and Lower Volume PEG-Asc With Bisacodyl	NCT02980562	Bowel Disease Colon Adenoma	Polyethylene Gl... Bisacodyl	20 Years - 75 Years	Korea University Anam Hospital

Spots Global Cancer Trial Database for polyethylene glycols