Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Cancer: Study Protocol of A Randomized, Open-Label, Multicentre Clinical Trial

In cancer, more than 30% of patients die due to cachexia and more than 50% of patients with cancer die with cachexia being present. Patients with cancer cachexia frequently develop a chronic negative energy and protein balance driven by a combination of reduced food intake and metabolic change. Several studies have already demonstrated the usefulness of oral nutritional supplements (ONS) in managing malnutrition of cancer patients. Though increased energy intake is very important in managing cancer-related malnutrition, the source of this extra energy and the presence of anti-inflammatory and immunonutritional components may also play an important role. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether an ONS composed according to the needs of patients with malignant diseases an ONS composed according to the needs of patients with malignant diseases is more effective than a general product in improving the nutritional status in cancer patients.

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Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Chronic Pulmonary Diseases: Study Protocol of a Randomized, Open-label, Multicentre Clinical Trial

Journal of Nutritional Biology ◽

10.18314/jnb.v4i2.1324 ◽

2018 ◽

Vol 4 (2) ◽

pp. 262-266

Author(s):

Edit Nadasi ◽

Gellert Cseh

Keyword(s):

Clinical Trial ◽

Study Protocol ◽

Nutritional Supplements ◽

Pulmonary Diseases ◽

Dietary Management ◽

Open Label ◽

Multicentre Clinical Trial ◽

Pulmonary Functions ◽

Oral Nutritional Supplements ◽

Chronic Pulmonary Diseases

Disease-related malnutrition is frequent in patients with chronic pulmonary diseases. Though there is no doubt about the usefulness of Oral Nutritional Supplements (ONS) in managing malnutrition in such patients, only a handful of publications are available in the literature on clinical trials with ONS in this patient population. Since the digestion of macronutrients results in a strain on the respiratory functions in severe pulmonary diseases, the source of energy may also play a crucial role in the efficacy of nutrition with ONS in such patients. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether a new, condition-specific ONS (with a composition tailored to the needs of patients with decreased pulmonary functions) is more effective compared to a general ONS in improving the nutritional status in patients with compromised respiratory functions.

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Phase II single arm open label multicentre clinical trial to evaluate the efficacy and side effects of a combination of gefitinib and methotrexate to treat tubal ectopic pregnancies (GEM II): study protocol

BMJ Open ◽

10.1136/bmjopen-2013-002902 ◽

2013 ◽

Vol 3 (7) ◽

pp. e002902 ◽

Cited By ~ 6

Author(s):

Andrew W Horne ◽

Monika M Skubisz ◽

Ann Doust ◽

W Colin Duncan ◽

Euan Wallace ◽

...

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Phase Ii ◽

Study Protocol ◽

Open Label ◽

Multicentre Clinical Trial ◽

Ectopic Pregnancies

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Comparison between High and Low Molecular Weight Hyaluronates in Knee Osteoarthritis Patients: Open-label, Randomized, Multicentre Clinical Trial

Journal of International Medical Research ◽

10.1177/147323000603400110 ◽

2006 ◽

Vol 34 (1) ◽

pp. 77-87 ◽

Cited By ~ 25

Author(s):

PB Lee ◽

YC Kim ◽

YJ Lim ◽

CJ Lee ◽

WS Sim ◽

...

Keyword(s):

Clinical Trial ◽

Molecular Weight ◽

Knee Osteoarthritis ◽

Low Molecular Weight ◽

Open Label ◽

Multicentre Clinical Trial

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First-line eradication rates comparing two shortened non-bismuth quadruple regimens againstHelicobacter pylori: an open-label, randomized, multicentre clinical trial

Journal of Antimicrobial Chemotherapy ◽

10.1093/jac/dkv089 ◽

2015 ◽

Vol 70 (8) ◽

pp. 2376-2381 ◽

Cited By ~ 21

Author(s):

Antonio Cuadrado-Lavín ◽

J. Ramón Salcines-Caviedes ◽

Ainhoa Diaz-Perez ◽

Miguel F. Carrascosa ◽

María Ochagavía ◽

...

Keyword(s):

Clinical Trial ◽

First Line ◽

Open Label ◽

Multicentre Clinical Trial

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Pharmacokinetics, SAfety/tolerability, and EFficacy of high-dose RIFampicin in tuberculosis-HIV co-infected patients on efavirenz- or dolutegravir-based antiretroviral therapy: study protocol for an open-label, phase II clinical trial (SAEFRIF)

Trials ◽

10.1186/s13063-020-4132-7 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Ruth Nabisere ◽

Joseph Musaazi ◽

Paolo Denti ◽

Florence Aber ◽

Mohammed Lamorde ◽

...

Keyword(s):

Clinical Trial ◽

Antiretroviral Therapy ◽

Phase Ii ◽

Study Protocol ◽

Phase Ii Clinical Trial ◽

High Dose ◽

Open Label ◽

Open Label Phase

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Study protocol for an open-label, single-arm, multicentre phase II trial to evaluate the efficacy and safety of combined triplet therapy and olanzapine for prevention of carboplatin-induced nausea and vomiting in gynaecological cancer patients

BMJ Open ◽

10.1136/bmjopen-2018-024357 ◽

2019 ◽

Vol 9 (1) ◽

pp. e024357

Author(s):

Hirotoshi Iihara ◽

Mototsugu Shimokawa ◽

Masakazu Abe ◽

Yoh Hayasaki ◽

Yukiyoshi Fujita ◽

...

Keyword(s):

Receptor Antagonist ◽

Cancer Patients ◽

Phase Ii ◽

Study Protocol ◽

Phase Ii Trial ◽

Emetogenic Chemotherapy ◽

Gynaecological Cancer ◽

Efficacy And Safety ◽

Open Label ◽

Multicentre Phase

IntroductionCarboplatin (CBDCA) administered at a dosage of 4 mg/mL/min or more area under the blood concentration-time curve (AUC) is considered to be ranked as the highest chemotherapy-induced nausea and vomiting (CINV) risk of the moderately emetogenic chemotherapy agents. The complete response (CR) rate for preventing overall CINV, defined as no emetic episodes and no use of rescue medication, for standard triplet antiemetic therapy (5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; NK1RA, neurokinin-1 receptor antagonist; DEX, dexamethasone) was approximately 60% in gynaecological cancer patients receiving CBDCA-based therapy. Further improvement in antiemetic treatment is needed to optimise care. This trial is to evaluate the efficacy and safety of using 5 mg olanzapine (OLZ) plus standard triplet antiemetic therapy for CINV after AUC ≥4 mg/mL/min CBDCA combination therapy in gynaecological cancer patients.Methods and analysisThis trial is an open-label, single-arm, multicentre phase II trial. Patients who receive CBDCA (AUC ≥4)-based therapy and have never been administered moderate to high emetogenic chemotherapy will be enrolled. All patients will receive OLZ (5 mg oral administration on days 1–4, after supper) in combination with 5-HT3RA, NK1RA and DEX. The primary endpoint is the CR rate during the overall period (0–120 hours). Testing the hypothesis that this regimen can improve CR rate from 60% (null hypothesis) to 75% (alternative hypothesis) with a one-sided type I error of 0.1 and power of 0.8 will require 53 patients. Considering the dropout rate, the target sample size is set at 60.Ethics and disseminationThe study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberUMIN000031646.

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Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

Trials ◽

10.1186/s13063-020-04498-6 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Bangjiang Fang ◽

Wen Zhang ◽

Xinxin Wu ◽

Tingrong Huang ◽

Huacheng Li ◽

...

Keyword(s):

Clinical Trial ◽

Study Protocol ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Open Label ◽

Randomized Controlled

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Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial

BMJ Open ◽

10.1136/bmjopen-2017-016269 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016269 ◽

Cited By ~ 7

Author(s):

Mikyung Kim ◽

Jung-Eun Kim ◽

Hye-Yoon Lee ◽

Ae-Ran Kim ◽

Hyo-Ju Park ◽

...

Keyword(s):

Clinical Trial ◽

Sleep Quality ◽

Usual Care ◽

Study Protocol ◽

Usual Care Group ◽

Sleep Diary ◽

Research Centre ◽

Care Group ◽

Patients With Cancer ◽

Patient Reported

IntroductionAlthough insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep.Methods and analysisThis is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment.Ethics and disseminationThis study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences.Trial registration numberKCT0002162; Pre-results.

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