Clinical trial · Interventional

Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer

Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study

NCT02295956CI-TRIAL-00039049completedEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Booklet	Other	—	UNRESOLVED
Exercise	Other	—	UNRESOLVED
Nutrition Counseling	Other	—	UNRESOLVED
Phone Calls	Behavioral	—	UNRESOLVED
Questionnaires	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Home Based Exercise and Nutrition Program
description
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.
interventionNames
1. Behavioral: Questionnaires
2. Other: Exercise
3. Other: Nutrition Counseling
4. Behavioral: Phone Calls
5. Other: Booklet

Primary outcomes (1)

measure
Feasibility of Prehabilitation Program Among Pancreatic Patients
timeFrame
6 weeks
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

1. Non-English speaking.
2. Unable to complete the baseline assessment questionnaires or functional assessments.
3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
4. 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.
5. Numeric pain rating scale of \>/= 7 out of 10.
6. Myopathic or rheumatologic disease that impacts physical function.

References

Publications (3)

DERIVEDKurz 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 35660135
DERIVEDNgo-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 31858837
DERIVEDParker 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 31592772

Registry

Dates and enrollment

Start: Feb 2, 2015
Primary completion: Jun 6, 2019
Completion: Jun 6, 2019
First posted: Nov 20, 2014
Last update posted: Jun 12, 2019
Enrollment: 75 (actual)
Lead sponsor: M.D. Anderson Cancer Center OTHER
Keywords: Pancreatic Cancer, Pancreatic adenocarcinoma, Preoperative therapy, Questionnaires, Surveys, Exercises, Stretching, Walking, Nutrition counseling, Resistance exercise bands, Phone calls, Booklet, Pamphlet

Data updated 22 days agoSource updated Jun 12, 2019source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.