Targeting Muscle-Bone Crosstalk Through Physical Therapy in Cancer Cachexia (PU-PTCC)

September 1, 2026 updated by: Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria

Targeting Muscle-Bone Crosstalk: The Potential of Physical Therapy in Managing Cancer-Induced Cachexia

This study investigates the role of a structured physical therapy (PT) program in managing cancer-induced cachexia (CIC) by targeting muscle-bone crosstalk. Cancer-induced cachexia leads to severe muscle wasting, systemic inflammation, and functional decline, which often limits treatment tolerance and quality of life. While exercise is known to attenuate protein breakdown and modulate muscle-derived cytokines (myokines), its specific impact on muscle-bone signaling in non-metastatic cancer patients undergoing chemotherapy remains underexplored. In this randomized controlled trial (RCT), patients aged 40 to 60 receiving neoadjuvant chemotherapy are assigned to either a control group receiving standard chemotherapy and nutritional counseling, or an experimental group receiving a progressive 3-month exercise program (combining aerobic treadmill training and resistance exercises) alongside standard care. The study aims to evaluate changes in biomarker levels (such as myokines and osteokines) and functional physical outcomes to determine whether targeted exercise can effectively attenuate cachexia and improve rehabilitation outcomes prior to surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cancer-induced cachexia (CIC) is a complex multifactorial syndrome characterized by progressive loss of skeletal muscle mass, systemic inflammation, metabolic dysregulation, and functional decline. The physiological interplay between skeletal muscle and bone tissue-known as muscle-bone crosstalk-is regulated through humoral signaling pathways involving myokines and osteokines. Key myokines, such as myostatin (an inhibitor of muscle growth), Interleukin-15 (IL-15, which promotes hypertrophy and fat oxidation), and decorin (which binds to myostatin to promote muscle growth), play pivotal roles in maintaining musculoskeletal homeostasis. Contractile activity during physical exercise can favorably modulate these myokine levels, reducing protein degradation and improving metabolic function. Despite the established systemic benefits of physical exercise, significant knowledge gaps remain regarding the clinical efficacy of structured physical therapy protocols specifically targeting muscle-bone crosstalk in young to middle-aged adults undergoing active cancer treatment. Furthermore, there is limited clinical data quantifying exercise-induced biological changes in circulating myokines (e.g., IL-15, decorin, SPARC) within non-metastatic cancer populations receiving neoadjuvant chemotherapy. This study is designed as a prospective Randomized Controlled Trial (RCT) to evaluate the therapeutic potential of a 3-month exercise intervention in patients aged 40-60 years with Grade 2/3 non-metastatic cancer undergoing neoadjuvant chemotherapy. Eligible participants are randomized into two parallel groups: Control Group: Receives standard care consisting of neoadjuvant chemotherapy accompanied by a structured nutritional support course following cachexia onset. Experimental Group: Receives a progressive 3-month physical therapy program in addition to standard neoadjuvant chemotherapy and nutritional support following cachexia onset. The 3-month physical therapy intervention combines structured aerobic and resistance training protocols: Aerobic Exercise: Treadmill walking performed 3 to 5 times per week (aiming for 150 minutes per week) at a progressive intensity ranging between 40% and 85% of maximum heart rate ($\text{HR}_{\text{max}}$). Resistance Exercise: Progressive strength training performed 2 to 3 times per week consisting of 2 sets of 8 to 10 repetitions at 50% to 70% of 1-repetition maximum (1RM)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older.

Confirmed diagnosis of non-metastatic cancer (Grade 2 or Grade 3).

Diagnosed with Cancer-Induced Cachexia (CIC) based on international consensus criteria (weight loss >5% in past 6 months, OR weight loss >2% in individuals with BMI <20 kg/m², OR appendicular skeletal muscle index consistent with sarcopenia).

Scheduled for or currently receiving standard neoadjuvant chemotherapy.

Ability to provide written informed consent and follow a structured physical therapy program.

ECOG Performance Status of 0 to 2.

Exclusion Criteria:

  • Evidence of distant tumor metastasis (Grade 4 cancer).

Severe orthopedic, neurological, or cardiovascular conditions preventing participation in safe physical therapy exercise.

Uncontrolled cardiovascular disease (e.g., unstable angina, recent myocardial infarction, severe cardiac arrhythmias).

Severe bone metastases or pathologic fracture risk that contraindicates weight-bearing exercises.

Prior participation in regular structured aerobic or resistance exercise training within the past 6 months.

Cognitive impairment or psychiatric conditions interfering with treatment compliance or informed consent.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Participants receive a structured 3-month physical therapy exercise protocol combining aerobic treadmill training (3-5 days/week) and progressive resistance training (2-3 days/week) alongside standard neoadjuvant chemotherapy and nutritional support.
Other: Structured Physical Therapy Exercise Program

Experimental Group):

A 3-month progressive physical therapy program consisting of aerobic exercise (treadmill walking 3-5 times per week, 150 min/week total, at 40%-85% HRmax) and resistance exercise (2-3 times per week, 2 sets of 8-10 repetitions at 50%-70% 1RM) combined with standard neoadjuvant chemotherapy and nutritional support Standard care comprising neoadjuvant chemotherapy protocols along with routine clinical nutritional support provided upon cachexia diagnosis, with no formal exercise intervention.

Other Names:
  • Standard Care and Nutritional Support
Placebo Comparator: control group
Participants receive standard neoadjuvant chemotherapy accompanied by standard nutritional support following cachexia onset, without participating in the structured physical therapy program
Other: Structured Physical Therapy Exercise Program

Experimental Group):

A 3-month progressive physical therapy program consisting of aerobic exercise (treadmill walking 3-5 times per week, 150 min/week total, at 40%-85% HRmax) and resistance exercise (2-3 times per week, 2 sets of 8-10 repetitions at 50%-70% 1RM) combined with standard neoadjuvant chemotherapy and nutritional support Standard care comprising neoadjuvant chemotherapy protocols along with routine clinical nutritional support provided upon cachexia diagnosis, with no formal exercise intervention.

Other Names:
  • Standard Care and Nutritional Support

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Serum Biomarkers of Muscle-Bone Crosstalk
Time Frame: 3 month
Serum concentration changes of key muscle-bone crosstalk mediators, specifically Myostatin (MSTN) and Osteocalcin (OCN), evaluated via enzyme-linked immunosorbent assay (ELISA) to assess the impact of physical therapy on cachexia-induced muscle-skeletal degradation.
3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Muscle Strength
Time Frame: Baseline and 3 months post-intervention
Measured using a hand-grip dynamomete
Baseline and 3 months post-intervention
Change in Bone Mineral Density (BMD
Time Frame: Baseline and 3 months post-intervention
Measured using DEXA scan at the lumbar spine
Baseline and 3 months post-intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharos University in Alexandria

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pharous university cancer ptt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to protect patient confidentiality and clinical privacy.

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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