UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059115 |
|---|---|
| Receipt number | R000067627 |
| Scientific Title | A trial for feasibility and effectiveness of preHABilitation during NEOadjuvant chemotherapy in older patients with locally advanced Esophageal cancer |
| Date of disclosure of the study information | 2025/09/18 |
| Last modified on | 2025/09/18 01:01:22 |
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Basic information
Public title
A trial for feasibility and effectiveness of preHABilitation during NEOadjuvant chemotherapy in older patients with locally advanced Esophageal cancer
Acronym
A trial for feasibility and effectiveness of preHABilitation during NEOadjuvant chemotherapy in older patients with locally advanced Esophageal cancer
Scientific Title
A trial for feasibility and effectiveness of preHABilitation during NEOadjuvant chemotherapy in older patients with locally advanced Esophageal cancer
Scientific Title:Acronym
NEOHAB-E trial
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility, safety, and effects of prehabilitation during neoadjuvant chemotherapy in older patients with locally advanced esophageal cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adherence to the intervention program: adherence rate to the exercise and nutrition program (from the initiation of neoadjuvant chemotherapy to the completion of the final cycle)
Key secondary outcomes
Safety of the intervention program (proportion of Grade 2 or more adverse events attributable to the exercise and nutrition program, assessed from initiation to completion of neoadjuvant chemotherapy cycles); skeletal muscle mass (Skeletal Muscle Mass Index [SMI] calculated from L3 CT images); physical activity (Global Physical Activity Questionnaire [GPAQ]); oral intake (Brief-type self-administered Diet History Questionnaire [BDHQ]); physical fitness (Incremental Shuttle Walk Test [ISWT]); nutritional status (body weight); functional status (WHO Disability Assessment Schedule ver. 2.0); and postoperative complications within 30 days (Clavien-Dindo classification grade II or higher).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention domains of prehabilitation during neoadjuvant chemotherapy consist of exercise and nutritional interventions, delivered through alternating inpatient (education phase) and outpatient (self-management phase: home-based intervention) settings. Patients are instructed to use a prehabilitation notebook/diary to support self-management of exercise and nutrition. The intervention period is defined as the duration from the day following the initiation of neoadjuvant chemotherapy until the T2 assessment after completion of the final chemotherapy cycle. The number of intervention sessions corresponds to the number of chemotherapy cycles administered (minimum of 1 and maximum of 3 interventions).
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients pathologically diagnosed with thoracic esophageal cancer (squamous cell carcinoma).
Patients scheduled to undergo curative resection following neoadjuvant therapy with the DCF regimen.
Patients aged 65 or more years at the time of enrollment.
Patients with an ECOG Performance Status of 0 to 2.
Patients capable of oral intake at the time of enrollment (Dysphagia score 2 or lower).
Patients able to provide written informed consent.
Patients able to understand the procedures for using an activity monitor and rehabilitation notebook.
Patients prior to the initiation of neoadjuvant therapy.
Key exclusion criteria
Presence of systemic infection requiring treatment.
Presence of fever 38 or more degrees Celsius.
Presence of psychiatric disorders or psychiatric symptoms that are judged to make participation in the trial difficult.
Receiving continuous systemic administration of corticosteroids (oral or intravenous).
Presence of uncontrolled hypertension.
Presence of unstable angina (new onset or worsening angina within the past 3 weeks) or history of myocardial infarction within the past 6 months.
Presence of severe interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, or acute heart failure.
History of cerebrovascular disease (such as cerebral infarction, intracerebral hemorrhage, or transient ischemic attack) within the past 6 months.
Presence of active double cancer (*1).
Any other condition judged by the principal investigator to make the patient unsuitable for enrollment in this clinical trial.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | HARADA |
Organization
National Cancer Center Hospital East
Division name
Department of Rehabilitation Medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
+81-4-7133-1111
tsuyoshi6167@gmail.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | HARADA |
Organization
National Cancer Center Hospital East
Division name
Department of Rehabilitation Medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
+81-4-7133-1111
Homepage URL
tsuyoshi6167@gmail.com
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
Tel
+81-4-7133-1111
tsuyoshi6167@gmail.com
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
国立長寿医療研究センター（愛知県）、名古屋大学大学院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 18 | 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 | 09 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067627
