NCT02295956

Brief Summary

The goal of this research study is to learn if it is possible to start a home-based exercise and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer before surgery (pre-operative rehabilitation, also known as prehabilitation).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for early_phase_1 pancreatic-cancer

Timeline
Completed

Started Feb 2015

Typical duration for early_phase_1 pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

4.3 years

First QC Date

November 18, 2014

Last Update Submit

June 10, 2019

Conditions

Pancreatic Cancer

Keywords

Pancreatic CancerPancreatic adenocarcinomaPreoperative therapyQuestionnairesSurveysExercisesStretchingWalkingNutrition counselingResistance exercise bandsPhone callsBookletPamphlet

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Prehabilitation Program Among Pancreatic Patients

    Feasibility established if \> 60% of patients are adherent. Prehabilitation program deemed feasible if 60% or more of participants complete at least 60% of the weekly 150-minute combined walking and strengthening exercises during the 6-week preoperative period.

    6 weeks

Study Arms (1)

Home Based Exercise and Nutrition Program

EXPERIMENTAL

Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Exercise instructional booklet given to all participants describing all exercises. Participants to walk 20-30 minutes at least 3 times a week. Nutrition program discussed with participants. Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.

Behavioral: QuestionnairesOther: ExerciseOther: Nutrition CounselingBehavioral: Phone CallsOther: Booklet

Interventions

QuestionnairesBEHAVIORAL

Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete.

Also known as: Surveys
Home Based Exercise and Nutrition Program
ExerciseOTHER

Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Participants to walk 20-30 minutes at least 3 times a week. Participants issued a set of 3 resistance exercise bands with which the exercises can be performed.

Home Based Exercise and Nutrition Program
Nutrition CounselingOTHER

Within 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition.

Home Based Exercise and Nutrition Program
Phone CallsBEHAVIORAL

Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.

Home Based Exercise and Nutrition Program
BookletOTHER

Exercise instructional booklet given to all participants describing all exercises.

Also known as: Pamphlet
Home Based Exercise and Nutrition Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatic adenocarcinoma, biopsy-proven or suspected.
  • Scheduled for intended pancreatectomy, \> 4 weeks until planned resection.
  • Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer.
  • Able to understand the description of the study and willing to participate.
  • Able to understand the exercise intervention and able to maintain a daily exercise log.
  • Participant must have telephone access and agree to engage with telephone access with the research personnel.

You may not qualify if:

  • Non-English speaking.
  • Unable to complete the baseline assessment questionnaires or functional assessments.
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
  • Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention.
  • Numeric pain rating scale of \>/= 7 out of 10.
  • Myopathic or rheumatologic disease that impacts physical function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Houston

Houston, Texas, 77004, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • Kurz E, Hirsch CA, Dalton T, Shadaloey SA, Khodadadi-Jamayran A, Miller G, Pareek S, Rajaei H, Mohindroo C, Baydogan S, Ngo-Huang A, Parker N, Katz MHG, Petzel M, Vucic E, McAllister F, Schadler K, Winograd R, Bar-Sagi D. Exercise-induced engagement of the IL-15/IL-15Ralpha axis promotes anti-tumor immunity in pancreatic cancer. Cancer Cell. 2022 Jul 11;40(7):720-737.e5. doi: 10.1016/j.ccell.2022.05.006. Epub 2022 Jun 2.

    PMID: 35660135DERIVED

  • Ngo-Huang A, Parker NH, Bruera E, Lee RE, Simpson R, O'Connor DP, Petzel MQB, Fontillas RC, Schadler K, Xiao L, Wang X, Fogelman D, Sahai SK, Lee JE, Basen-Engquist K, Katz MHG. Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419894061. doi: 10.1177/1534735419894061.

    PMID: 31858837DERIVED

  • Parker NH, Lee RE, O'Connor DP, Ngo-Huang A, Petzel MQB, Schadler K, Wang X, Xiao L, Fogelman D, Simpson R, Fleming JB, Lee JE, Tzeng CD, Sahai SK, Basen-Engquist K, Katz MHG. Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. J Phys Act Health. 2019 Dec 1;16(12):1113-1122. doi: 10.1123/jpah.2019-0027. Epub 2019 Oct 7.

    PMID: 31592772DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsMotor Activity

Interventions

Surveys and QuestionnairesExercise

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Matthew H. Katz, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

February 2, 2015

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Locations

US(2)