Diet and Exercise After Pancreatic Cancer

NCT03187028 | Completed DMC

• 1 other identifier: F141218007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Determine feasibility of a randomized controlled trial (RCT) in pancreatic (\& other foregut) cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.

Conditions

Pancreatic Cancer

Keywords

Cancer of Pancreas; Neoplasms, Pancreatic; Pancreas Cancer; Pancreas Neoplasms; Cancer of the Pancreas; Pancreatic Cancer; Foregut Cancer

Outcome Measures

Primary Outcomes (5)

• Feasibility - Recruitment

  Number of participants excluded or not agreeing to participate

  Baseline

• Feasibility - Adherence to study protocol activities

  Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)

  Throughout 6 month study period

• Feasibility - Attrition rates

  Number of participants who dropout or are withdrawn

  Throughout 6 month study period

• Feasibility - Adverse events

  Recorded by staff

  Throughout 6 month study period

• Feasibility - Participant satisfaction

  Survey

  At conclusion of 6 month study period

Secondary Outcomes (10)

• Eastern Cooperative Oncology Group (ECOG) performance status

  At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)

• Quality of life (assessed using the Functional Assessment of Cancer Therapy index)

  At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)

• Objective physical functioning

  At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)

• CA 19-9 (tumor markers)

  At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)

• Completion of pancreatic cancer treatment

  At conclusion of 6 month study

Study Arms (2)

Diet only

ACTIVE COMPARATOR

Diet counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet counseling.

Behavioral: Diet Only

Diet + Exercise

EXPERIMENTAL

Diet and exercise counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet and exercise counseling also receiving a fitness bracelet to facilitate counseling by the certified Cancer Exercise Trainer.

Behavioral: Diet + Exercise

Interventions

Diet Only BEHAVIORAL

Diet counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet counseling.

Diet only

Diet + Exercise BEHAVIORAL

Diet and exercise counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet and exercise counseling.

Diet + Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult 18 years of age or older with resectable foregut cancer for whom surgery is planned (includes "borderline resectable" if deemed appropriate by surgical investigators) or has occurred within the past 3 years
• English speaking
• Eastern Cooperative Technology Group (ECOG) performance status of 0,1 or 2.
• able to ambulate without assistance
• able to obtain medical clearance

You may not qualify if:

• foregut cancer recurrence
• dementia or organic brain syndrome
• severe emotional distress
• medical, psychological or social characteristic that would interfere with the ability to fully participate in program activities and assessments
• another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ).
• oncologist refuses to allow screening for possible study participation
• current participation in another exercise trial

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 14, 2017
• Study Start: August 3, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-08

Locations

US (1)