Neoplasms

Digestive System Diseases

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Nutritional and Metabolic Diseases

Rare Diseases

Stomach Neoplasms

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively.

The control group was given no additional postoperative nutritional supplementation (standard diet).

NutrenOpimum

Zhiwei Zhou, Ph.D.

Runcong Nie, Ph.D.

Background: It is known that postoperative malnutrition remains inevitable for gastric cancer patients with adjuvant chemotherapy, which could have prejudicial influence on the compliance of subsequent adjuvant chemotherapy and survival of the patients. A multi-institutional prospective phase 2 study had demonstrated the efficacy of oral nutritional supplements (ONS) for gastric cancer patients undergoing gastrectomy. However, previous studies did not focus the gastric cancer patients with adjuvant chemotherapy. Thus, it is unknown whether the ONS could benefit the gastric cancer patients with adjuvant chemotherapy. A multicenter, phase 3 randomised controlled trial was conducted to compare the ONS with standard diet for postoperative gastric cancer patients with adjuvant chemotherapy. Patients and method: In this study, pathological confirmed stage II-III or T1N1M0 gastric cancer patients who are supposed to receive adjuvant chemotherapy, aged from 18 to 75 years, with body mass index (BMI) from 18.5 to 28.0 kg/m2, and with Eastern Cooperative Oncology Group performance status ≤2, are randomized 1:1 to receive oral administration of NutrenOpimum (Nestle Suisse S.A.), a liquid enteral nutritional food for special medical purpose (FSMP), or standard diet. NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was postoperative malnutrition, as defined as ratio of the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%; body weight loss ratio at 1, 3, 6 months. Secondary end points were chemotherapy withdrawal, time to adjuvant chemotherapy failure, period of adjuvant chemotherapy, quality of life, grade 3/4 neutropenia, thrombocytopenia, anemia, and severe side effects on digestive tract. Final study analysis will be conducted after the last patient's enrollment.

Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy

Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy: a Multicenter, Open-label, Phase 3 Randomised Controlled Trial

the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%

the ratio of the weight loss at 1,3,6 months postoperatively to the days 7 postoperatively body weight

chemotherapy withdrawal by the adverse events or recurrence

Time to adjuvant treatment chemotherapy failure (TTF) were calculated using the Kaplan-Meier method and compared by the log-rank test

quality of life at 1,3 and 6 months as evaluated by EORTC QLQ-C30

grade 3/4 neutropenia, thrombocytopenia, anemia during adjuvant chemotherapy

severe side effects on digestive tract during adjuvant chemotherapy

Sun Yat-sen University

Professor

Adenocarcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Group that be scheduled to undergo chemothrapy only using FOLFOX4 protocol.

Group that not only be scheduled to undergo chemothrapy using FOLFOX4 protocol,but also receive colonscopy-assisted PDT.

Each patient to whom PDT was offered underwent a specific, detailed educational process by a dedicated team member(P.B., P.J., or K.E.), after which informed consent was obtained.Porfimer sodium (Photofrin; Axcan Pharma Inc, Quebec, Canada)was used as a photo sensitizing agent, administered intravenously at a dose of 2 mg/kg body weight 48 hours before illumination.A diode laser system (InGaAIP Laser Diode; Diomed Inc, An-dover, MA) with a maximum power output of 2000 mW and a wavelength of 633+-3 nm was used as a light source, delivered through a 3.0-m length fiber having a 2.5-cm-long cylindrical diffuser at its distal end (Pioneer Optics, Windsor Locks, CT).

Photodynamic therapy

This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through colonscopy compared with chemotherapy alone in patients presenting with advanced rectal cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy	NCT03654534	Gastric Cancer	NutrenOpimum	18 Years - 75 Years	Sun Yat-sen University
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer	NCT01872104	Advanced Rectal...	Photodynamic th...	25 Years - 75 Years	Central South University
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer	NCT01872104	Advanced Rectal...	Photodynamic th...	25 Years - 75 Years	Central South University
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer	NCT01872104	Advanced Rectal...	Photodynamic th...	25 Years - 75 Years	Central South University
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer	NCT01872104	Advanced Rectal...	Photodynamic th...	25 Years - 75 Years	Central South University

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Spots Global Cancer Trial Database for chemothrapy

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