UMIN-CTR Clinical Trial

Public title

A phase II study about the efficacy of an intervention of excercise therapy on the adjuvant chemotherapy for pancreatic cancer: Exercise-PC Study

Acronym

Exercise impact on adjuvant chemotherapy for pancreatic cancer

Scientific Title

A phase II study about the efficacy of an intervention of excercise therapy on the adjuvant chemotherapy for pancreatic cancer: Exercise-PC Study

Scientific Title:Acronym

Exercise impact on adjuvant chemotherapy for pancreatic cancer

Region

Japan

Condition

Invasive ductal adenocarcinoma of pancreas

Classification by specialty

Hepato-biliary-pancreatic surgery

Rehabilitation medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We evaluate the efficacy of an S-1 adjuvant chemotherapy combined with a supervised exercise program for pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The completion rate of four courses of S-1 adjyvant chemotherapy.

Key secondary outcomes

1. Relative dose intensity of S-1: Until 6 months after the first day of adjuvant therapy
2. Recurrence free survival time
3. Overall survival time
4. Safety of the protocol therapy of this study: Until 6 months after the first day of adjuvant therapy
5. Questionnaires about fraility, EORTC QLQ-C30 SF-36

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Exercise Therapy:
[Peoperative]
1.Squat,Heel raise,Gluteus medius muscle training 60min
2.Exercise bile 60-70%HRR 30min
3.Hand ergo 60-70%HRR 20min
4.Stepping the stairs
5.Voluntary training
[Postoperative]
POD1-5: Corridor walking
POD5-7: Mild to moderate squat, Stepping the stairs
POD7-: Exercise bike, Hand ergo
Goalof discharge: 70% of body power on admission
[After discharge]
Exercise outpatient clinic:
3days/week
1. Squat,Heel raise,Gluteus medius muscle training 60min
2. Exercise bike
3. Hand ergo
4. Stepping the stairs
5. Voluntary training

Six min walk test on admission and discharge, and aerobic exercise was programmed based on CPX (Cardiopulmonary Exercise Training) on discharge.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with resected pancreatic cancer that was a histologically verified invasive ducal carcinoma of the pancreas (StageI/II or stage III combined resected with artery based on UICC ver.8).
2. Local residual tumor classified as R0 or R1.
3. Cytologic examination negative upon intraoperative peritoneal lavage
4. Until 10 weeks after surgery
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
6. Age of 20 years or above
7. Written informed consent given

Key exclusion criteria

1. Severe drug hypersensitivity or drug allergy
2. Multiple primary cancers within 5 years.
3. Severe infection
4. With watery diarrhea
5. Interstitial pneumonia or pulmonary fibrosis
6. With uncontrollable pleural effusion or ascites
7. With uncontrollable diabetes mellitus
8. With severe heart failure, angina, hypertension, arrhythmia
9. Walking akinesia
10. With severe malnutrition
11. With severe neurological/psychological symptoms
12. Pregnant or lactating women or women with unknown or suspected pregnancy

Target sample size

44

Name of lead principal investigator

1st name	Ken-ichi
Middle name
Last name	Okada

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

641-8510

Address

Kimiidera 811-1, Wakayama City

TEL

073-441-0613

Email

okada@wakayama-med.ac.jp

Name of contact person

1st name	Ken-ichi
Middle name
Last name	Okada

Organization

Wakayama Medical University

Division name

Second Department of surgery

Zip code

641-8510

Address

Kimiidera 811-1, Wakayama City

TEL

073-441-0613

Homepage URL

Email

okada@wakayama-med.ac.jp

Institute

Wakayama Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Wakayama Medical University

Address

Kimiidera 811-1, Wakayama City

Tel

073-447-2300

Email

warinri@wakayama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

26

Day

URL releasing protocol

doi: 10.1097/XCS.0000000000000408

Publication of results

Published

URL related to results and publications

doi: 10.1097/XCS.0000000000000408

Number of participants that the trial has enrolled

43

Results

The completion rate of S-1 therapy, which is the primary endpoint, was 93% , which exceeded the threshold completion rate of 53% (P < 0.001).

Results date posted

2022

Year

11

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We assessed improvement of the completion rate of adjuvant chemotherapy in patients who underwent macroscopic resection of pathologically diagnosed PDAC.

Participant flow

117 patients who underwent surgery were assessed for eligibility. Two patients were ineligible, and 72 patients refused to participate, so 43 patients were enrolled in this study

Adverse events

Safety of the exercise therapy treatment protocol
None of the enrolled patients failed to continue exercise treatment due to physical injury or breakdown from the protocol treatment.

Outcome measures

The completion rate of S-1 therapy, which is the primary endpoint, was 93% (95% confidential interval [80.9%, 98.5%]), which exceeded the threshold completion rate of 53% (P < 0.001) . Only three patients (7%) discontinued treatment before completion, and recurrence of primary disease was the reason for discontinuation in each case. Subgroup analyses of completion rate revealed no significant differences between the groups: PD (92%) vs. DP (100%) (P = 0.232), upfront surgery (95%) vs. preoperative treatment (92%) (P = 0.694), and exercise with 85% HRR (94%) vs. 70% HRR (91%) (P = 0.749). As secondary endpoints, the relative dose intensity of S-1 was 100.0 [95.9,100.0] (median (IQR)), the median recurrence-free survival was 20.4 months, and the median overall survival was not reached , confirming the safety of protocol treatment.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

11

Month

23

Day

Date of IRB

2017

Year

12

Month

05

Day

Anticipated trial start date

2017

Year

12

Month

05

Day

Last follow-up date

2020

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

11

Month

26

Day

Last modified on

2022

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034394