UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045594 |
|---|---|
| Receipt number | R000050738 |
| Scientific Title | A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer |
| Date of disclosure of the study information | 2021/09/29 |
| Last modified on | 2024/07/31 13:38:11 |
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Basic information
Public title
A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer
Acronym
A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer
Scientific Title
A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer
Scientific Title:Acronym
A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Hematology and clinical oncology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether supplementation with collagen peptide-containing beverage (V CRESC) is able to maintain adequate nutrition via oral intake in patients with head and neck cancer receiving chemoradiotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of patients able to obtain adequate nutrition via oral intake when the total radiation dose reached 42-50 Gy
Key secondary outcomes
Frequency of use of percutaneous endoscopic gastrostomy (PEG) for nutrition support
Compliance with collagen peptide-containing beverage (V CRESC) use
Serum albumin, total protein, and C-reactive protein at the initiation and the end of chemoradiotherapy
Body weight loss from the initiation to the end of chemoradiotherapy
Maximum dose of opioid used
Adverse events associated with chemoradiotherapy, including oral mucositis, loss of appetite, nausea, vomiting, diarrhea, aspiration, and infection
PRO-CTCAE
Compliance with chemoradiotherapy
Weekly total calories (kcal/day) and protein (kcal/day) during chemoradiotherapy surveyed by dieticians
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of collagen peptide (V CRESC)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Age over 20 years
(ii) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1
(iii) Patients with head and neck cancer who will undergo definitive chemoradiotherapy or postoperative adjuvant chemoradiotherapy
(iv) Be to receive over 50 Gy of irradiation for pharyngeal space or oral space
(v) Be to receive cisplatin-based chemoradiotherapy
(vi) Adequate hematological, liver and renal functions.
(vii) Sufficient eating ability, normalcy of diet in performance status scale for head and neck cancer patients (PSSHN)>=50
(viii) Able to obtain more than 80% of required calorie calculated by Harris-Benedict Equation via oral intake at the initiation of chemoradiotherapy
(ix) Absence of oral mucositis and dry mouth evaluated by CTCAE version 5.0
(x) Written informed consent was obtained from each patient
Key exclusion criteria
i. Patients who are taking supplement or drugs containing collagen peptide, and who will continue to take them throughout the chemotherapy
ii. Patients who will receive palliative chemoradiotherapy
iii. Women who are pregnant, contemplating pregnancy or amid breast-feeding
iv. Mental disorders which is considered inappropriate for inclusion in the study
v. Protein intake restriction
vi. Hypersensitivity to the element of V CRESC
vii. Unable to take V CRESC per oral
viii. Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Yokota |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan
TEL
055-989-5222
t.yokota@scchr.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Yokota |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan
TEL
055-989-5222
Homepage URL
t.yokota@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
NUTRI CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan
Tel
055-989-5222
kenkyusuishin@scchr.jp
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
静岡県立静岡がんセンター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
33
Results
The proportion of patients who were able to obtain adequate nutrition via oral intake upon the administration of a radiotherapy dosage of 42-50 Gy was 57.6%.
Results date posted
| 2024 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with head and neck cancer who underwent definitive chemoradiotherapy or postoperative adjuvant chemoradiotherapy with cisplatin-based chemotherapy; scheduled receipt of > 50 Gy irradiation to the pharyngeal space or oral space; sufficient eating ability; normalcy of diet evaluated with the Performance Status Scale for Head and Neck cancer patients (PSSHN) more than 50; able to obtain more than 80% of required calorie calculated by Harris-Benedict Equation via oral intake at the initiation of chemoradiotherapy were enrolled.
Participant flow
Patients received one bottle of collagen peptide supplement (V CRESC CP10;NUTRI Co.,Ltd.) daily, from the first day until the last day of radiotherapy.
Adverse events
The incidence of more than grade 3 adverse events included oral mucositis (39.4%), anorexia (30.3%), and nausea (9.1%). No other remarkable adverse events related to treatment interruption were observed.
Outcome measures
Primary endpoint:
The proportion of patients who are able to obtain adequate nutrition via oral intake upon the administration of a radiotherapy dosage of 42-50 Gy
Secondary endpoints:
Frequency of use of percutaneous endoscopic gastrostomy for nutrition support
The compliance with collagen peptide uptake
Serum albumin, total protein, and C-reactive protein at chemoradiotherapy initiation and chemoradiotherapy completion
Body weight loss from chemoradiotherapy initiation to chemoradiotherapy completion
Maximum dose of opioid used
Adverse events
PRO-CTCAE
Compliance of chemoradiotherapy
Total calories (kcal/day) and protein (kcal/day) surveyed weekly by dieticians
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050738
