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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | |
Unique ID issued by UMIN | UMIN000024045 |
Receipt No. | R000027690 |
Scientific Title | The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer. |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2016/09/14 |
Basic information | ||
Public title | The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer. | |
Acronym | The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer. | |
Scientific Title | The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer. | |
Scientific Title:Acronym | The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer. | |
Region |
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Condition | |||
Condition | Head and neck cancer. | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate of efficacy of enteral supplementation product enriched with L-glutamine in patients with head and neck cancer. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | CTCAE score for inflammation of oral pharyngeal mucosa. |
Key secondary outcomes | 1)Physical measurement
Body weight, Lean body weight, body fat mass, Grip strength 2)Digestive symptom oral mucositis, taste disturbance, diarrhea, appetite 3)score of Quality of life(QOL) EORT-QLQ-C30 4)Blood test Alb,TP,PA,RBP,serum diamine oxidase activity,IL-6,active ghrelin 5)Amount of total Energy by oral feeding, enteral feeding, parenteral nutrition 6)Duration and dosage of opioid. 7)Rate of CRT completion. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | L-glutamine group: L-glutamine(1-3 pack per day) from 4days before to end of CRT. | |
Interventions/Control_2 | Control group: Placebo(1-3 pack per day) from 4days before to end of CRT. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Aged >= 20
2) Patients with head and neck cancer. 3) Patients who receive chemoradiotherapy. 4) Recovered from previous chemotherapy and radiotherapy toxicities. 5) Patients who obtained the consent. |
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Key exclusion criteria | 1)Unable intake glutamine formulations per oral or per enteral tube.
2)major impairment of liver 3)major impairment of kidney 4)allergic to L-glutamine 5)pregnant,lactating 6)presence of other cancer under treatment. 7)severe psychosis or psychiatric symptoms 8)paticipation judged by physician to be inadvisable 9)paticipation not taking opioids |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shiga University of Medical Science Hospital | ||||||
Division name | Clinical nutrition | ||||||
Zip code | |||||||
Address | Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192 | ||||||
TEL | 077-548-2519 | ||||||
kuri@belle.shiga-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Shiga University of Medical Science Hospital | ||||||
Division name | Clinical nutrition | ||||||
Zip code | |||||||
Address | Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192 | ||||||
TEL | 077-548-2519 | ||||||
Homepage URL | |||||||
maiapril@belle.shiga-med.ac.jp |
Sponsor | |
Institute | Shiga University of Medical Science Hospital |
Institute | |
Department |
Funding Source | |
Organization | Aido Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
Participant flow | |
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IPD sharing Plan description |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027690 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |