NCT07470268

Brief Summary

To determine the efficacy of a 12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass, physical function, and quality of life in patients with unresectable pancreatic cancer compared to standard care.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
12mo left

Started Sep 2026

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 3, 2026

Last Update Submit

March 16, 2026

Conditions

Pancreatic Cancer

Keywords

physical activityphysical functionbody compositionlean masschemotherapy

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    The main objective of this study is to evaluate the effect on body composition (primarily lean mass) through 12 weeks of hypertrophy training in patients with advanced, non-operable pancreatic cancer undergoing treatment

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • VO2peak

    Through study completion, an average of 1 year

  • Patient-reported outcome measures

    Through study completion, an average of 1 year

  • Anxiety and Depression

    Through study completion, an average of 1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

12 weeks of hypertrophy training in patients with advanced, unresectable PC receiving chemotherapy and/or immunotherapy

Other: supervised, hypertrophy-oriented strength training program

Control Group

NO INTERVENTION

Participants in the control group will receive standard oncological treatment. No restrictions on physical activity will be imposed. Furthermore, they will be offered the opportunity to follow the exercise program used in the intervention group if the expected benefits proposed in the study hypothesis are confirmed.

Interventions

supervised, hypertrophy-oriented strength training programOTHER

12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of locally advanced or metastatic unresectable pancreatic cancer
  • Undergoing chemotherapy or immunotherapy treatment
  • Age ≥ 18 years
  • ECOG score ≤ 2

You may not qualify if:

  • Any relative or absolute contraindication that prevents the performance of training or physical tests.
  • Diagnosis of other types of primary cancer
  • Inability to understand Spanish for proper comprehension of the informed consent and questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data will be available, including de-identified individual participant data, data dictionaries, and study protocols.

Shared Documents
STUDY PROTOCOL
Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact investigacion@universidadeuropea.es

Locations

ES(1)