UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058013 |
|---|---|
| Receipt number | R000066304 |
| Scientific Title | A phase II study of the safety and efficacy of the neoadjuvant chemotherapy with home-based exercise program for pancreatic cancer |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/29 15:22:48 |
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Basic information
Public title
A phase II study of the safety and efficacy of the neoadjuvant chemotherapy with home-based exercise program for pancreatic cancer
Acronym
A phase II study of neoadjuvant adjuvant chemotherapy with exercise program for pancreatic cancer
Scientific Title
A phase II study of the safety and efficacy of the neoadjuvant chemotherapy with home-based exercise program for pancreatic cancer
Scientific Title:Acronym
A phase II study of neoadjuvant adjuvant chemotherapy with exercise program for pancreatic cancer
Region
| Japan |
Condition
Condition
Invasive ductal adenocarcinoma of pancreas
Classification by specialty
| Hepato-biliary-pancreatic surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of preoperative adjuvant chemotherapy for pancreatic cancer combined with home-based exercise therapy on the lymphocyte-to-monocyte ratio (LMR) and other inflammatory based prognostic scores (IBPS). In addition, we will examine whether the practice of exercise therapy contributes to a decrease in postoperative complications, an increase in the completion rate of adjuvant chemotherapy, and a prolongation of recurrence-free survival. In addition, we will examine how exercise therapy changes the tumor microenvironment and how it correlates with IBPS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lymphocyte-monocyte ratio (LMR) before and after preoperative adjuvant chemotherapy with home-based exercise therapy: rate of increase in the high LMR group when the cutoff value for LMR is 3.0.
Key secondary outcomes
1) Evaluation of nutritional immunological parameters (Inflammation-based prognostic score: IBPS) (prealbumin level, albumin level, neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), prognostic nutrition index (PNI), controlling nutritional status (CONUT))
(2) Relative dose intensity of preoperative adjuvant chemotherapy
3) Incidence of postoperative complications (Dindo Classification Grade III or higher)
4) Completion rate of adjuvant chemotherapy
5) Recurrence-free survival, 2-year recurrence-free survival
6) Safety of protocol treatment (adverse events)
7) Changes in body composition (muscle mass, fat mass, body fat percentage, etc.)
8) Evaluation of tumor microenvironment in resected histopathology specimens (evaluation of CD3, CD4, and CD8 T lymphocyte infiltration at the tumor margins and interior, and tumor-associated macrophage infiltration)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Home-based exercise therapy
1. Aerobic exercise
Fast walking with modified Borg Scale 4 or higher for a total of at least 30 minutes per day, at least 4 times per week.
2. 3-minute muscle training
A: Leg raises, squats
B: Push-ups, back extensions
A and B menus are alternated three times a week for a total of six times a week.
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
1. 20 years of age or older
2. Histopathological or cytological diagnosis of pancreatic adenocarcinoma
3. Patients with an ECOG score of 0 or 1.
4. No evidence of distant metastasis on imaging tests
5. Patients who have been fully informed and have given their free and voluntary written consent to participate in this study.
Key exclusion criteria
1. Patients in which consent for participation in the research cannot be obtained from the research subject himself/herself
2. Patients with a history of serious drug hypersensitivity or allergy
3. Patients with a history of malignant tumors (*Cases with a recurrence-free period of at least 5 years, and cases of endoscopically curatively resected intramucosal cancer, curatively resected cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin may be registered)
4. Patients with active infection
5. Patients with diarrhea (Grade 3 or higher)
6. Patients with a history of interstitial pneumonia or pulmonary fibrosis
7. Patients with hepatic or renal dysfunction that precludes chemotherapy
8. Patients with uncontrolled ascites or pleural effusion
9. Patients with uncontrolled diabetes mellitus
10. Patients with uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmia
11. Patients with inability to ambulate
12. Patients with severe malnutrition
13. Patients with a history of serious neurological or psychiatric diseases or complications
14. Pregnant women, lactating women, and patients with the possibility (intention) of pregnancy.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University
Division name
Department of Gastroenterological Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara city, Kanagawa
TEL
0463-93-1121
kokada@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Mashiko |
Organization
Tokai University
Division name
Department of Gastroenterological Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara city, Kanagawa
TEL
0463-93-1121
Homepage URL
mt0172@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara city, Kanagawa
Tel
0463-93-1121
tokai-rec@tokai.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
| 2025 | Year | 05 | Month | 29 | 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 | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2029 | Year | 12 | 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
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066304
