Impact of Hypertrophy-oriented Resistance Training on Muscle Mass and Quality of Life in Patients With Unresectable Pancreatic Cancer (HY-PANC)

March 16, 2026 updated by: Lidia Brea Alejo, Universidad Europea de Madrid

Impact of Hypertrophy-oriented Resistance Training on Muscle Mass and Quality of Life in Patients With Unresectable Pancreatic Cancer (HY-PANC): Study Protocol for a Randomized Controlled Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Two-arm randomized controlled trial will recruit patients with unresectable pancreatic cancer undergoing chemotherapy. Participants will be randomized (1:1) to an Intervention Group (resistance training twice weekly) or a Control Group (standard care). The primary outcome is the change in total lean body mass (assessed by DXA) at week 12. Secondary outcomes include maximal strength, peak power, cardiorespiratory capacity, and patient-reported measures.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
12 weeks of hypertrophy training in patients with advanced, unresectable PC receiving chemotherapy and/or immunotherapy
Other: supervised, hypertrophy-oriented strength training program
12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2peak
Time Frame: Through study completion, an average of 1 year
• To analyze whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy has an impact on cardiorespiratory capacity.
Through study completion, an average of 1 year
Patient-reported outcome measures
Time Frame: Through study completion, an average of 1 year
• To identify whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy impacts on quality of life. To assess quality of life, the European Organisation for Research and Treatment of Cancer quality of life Questionnaire C30 (EORTC QLQ-C30), version 3.0 will be used. The questionnaire consists of 30 questions grouped into several scales, with higher scores (0-100) indicating better functioning or higher symptom burden.
Through study completion, an average of 1 year
Anxiety and Depression
Time Frame: Through study completion, an average of 1 year
• To determine whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy has an impact on anxiety and depression. It will be assesed through the validated questionnaire for assessing anxiety and depression in cancer patients, the Hospital Anxiety and Depression Scale (HADS). It is a 14-item, self-report screening tool used to identify and monitor emotional distress (anxiety and depression) in patients with physical health conditions. It consists of two subscales (7 questions each for anxiety and depression) and is commonly used in hospital settings.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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