UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059146 |
|---|---|
| Receipt number | R000066489 |
| Scientific Title | Multimodal Intervention for Sarcopenia in Nasopharyngeal Carcinoma Patients Undergoing Definitive Treatment: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2025/09/20 10:04:35 |
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Basic information
Public title
A Study to Test a Combined Program to Prevent Muscle Loss in Patients with Nasopharyngeal Cancer Receiving Chemotherapy and Radiotherapy
Acronym
ASTCPPMLPNCRCR
Scientific Title
Multimodal Intervention for Sarcopenia in Nasopharyngeal Carcinoma Patients Undergoing Definitive Treatment: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
MISNCPUDTAPRCT
Region
| Asia(except Japan) |
Condition
Condition
Nasopharyngeal carcinoma (NPC) undergoing definitive chemoradiotherapy
Classification by specialty
| Hematology and clinical oncology | Oto-rhino-laryngology | Rehabilitation medicine |
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This pilot randomized controlled trial aims to (1) assess the feasibility of implementing a multimodal nonpharmacological intervention model for sarcopenia prevention in nasopharyngeal carcinoma patients undergoing definitive chemoradiotherapy, and (2) estimate the effect size of the intervention on clinical outcomes to inform the design of a future full-scale randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of the Multimodal Intervention:The primary objective is to evaluate the feasibility of implementing a multimodal intervention for sarcopenia prevention in clinical settings. Feasibility will be assessed across the following dimensions:
Acceptability. Assessed through semi-structured interviews with patients and MDT members after the intervention, exploring experiences, perceptions of individual components (nutrition, exercise, symptom management, and psychological support), and perceived burden (Appendix K). Additionally, a structured Patient Satisfaction Survey (Appendix M) will be used to assess satisfaction quantitatively.
Demand. Evaluated by recruitment and consent rates, session attendance, retention, and documented reasons for withdrawal or non-participation.
Implementation Fidelity. Measured using standardized checklists to ensure core components are delivered as intended.
Practicality and Adaptability. Assessed via resource utilization (e.g., staff time, materials), cost per participant, disruptions to workflow, and feedback from healthcare staff on barriers/facilitators and integration potential.
Key secondary outcomes
Sarcopenia prevalence
Body composition changes
Symptom burden (The head and neck symptom checklist)
Nutritional status (PG-SGA scale)
Biomarkers
(a) GINI (Global Immune-Nutrition-Inflammation Index)
(b) HALP (Hemoglobin, Albumin, Lymphocyte, Platelet Score)
(c) PNI (Prognostic Nutritional Index)
The exercise adherence score
Food Implementation Rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Initial Assessment and Planning: The head nurse (PI) leads the MDT to assess each patient fully. A personalized plan with nutrition and exercise is made. The head nurse supervises the intervention.
Personalized Health Education : Four face-to-face sessions are done by nurses with a family member. Topics cover disease info, psychological prep, side effects, immune nutrition, and safe exercise. Patients and family keep weekly 3-day food and exercise logs for feedback.
Weekly Monitoring: Starting from induction chemotherapy, nurses assess diet, body status, symptoms, and adherence weekly. Nurses give advice to help meet goals.
MDT Case Consultations: The head nurse sets MDT meetings for special cases for group review and tailored care.
Key MDT Meetings: Meetings at key points present assessments, discuss issues, and update plans.
Final Review: After intervention ends, MDT reviews the case to assess results and guide future work.
Interventions/Control_2
Participants in the control group will receive the standard care currently practiced at the study hospital. This includes routine nutritional and physical activity education provided by nurses at the time of diagnosis, along with nutritional risk screening conducted by physicians using the Nutritional Risk Screening 2002 (NRS-2002) tool. When clinically indicated, such as in cases of significant weight loss, patients will be referred to a dietitian through an internal system for a one-time assessment and individualized dietary advice. However, ongoing nutritional follow-up is not routinely provided.
Exercise guidance is limited to general recommendations during initial education and is not tailored or systematically monitored. Sarcopenia screening and structured tracking of physical activity are not standard components of usual care. Side effects are assessed and managed by physicians and nurses during regular outpatient visits, although this is not supported by a standardized symptom-monitoring protocol.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for eligible patients are: Participants must have a confirmed diagnosis of nasopharyngeal carcinoma by histology and be undergoing initial concurrent chemoradiotherapy. They must be between 18 and 80 years old, have an ECOG performance status from 0 to 2, have intact limb function, and have at least one family member who can attend health education sessions and assessments with them.
Key exclusion criteria
The exclusion criteria include patients having: sarcopenia and/or other malignant tumors before treatment, mental illness or cognitive impairment,implanted pacemakers,hearing or visual impairments or aphasia, and physical activity restrictions due to multiple cardiovascular diseases, poorly con-trolled hypertension, or bronchial asthma.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Lijuan |
| Middle name | |
| Last name | Xia |
Organization
St. Luke's International University
Division name
Dept. of Oncology Nursing and Palliative Care/ Chronic Illness and Conditions Nursing
Zip code
104-0044
Address
10-1 Akashicho, Chuo-ku, Tokyo
TEL
07091451388
24dn009@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Lijuan |
| Middle name | |
| Last name | Xia |
Organization
St. Luke's International University
Division name
Dept. of Oncology Nursing and Palliative Care/ Chronic Illness and Conditions Nursing
Zip code
104-0044
Address
10-1 Akashicho, Chuo-ku, Tokyo
TEL
07091451388
Homepage URL
24dn009@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Lijuan Xia
Funding Source
Organization
Hasegawa International Scholarship
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
10-1 Akashicho, Chuo-ku, Tokyo
Tel
03-5550-2259
naoko-hayashi@slcn.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | Day |
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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066489
