Targeting Muscle-Bone Crosstalk Through Physical Therapy in Cancer Cachexia

NCT07807306 | Not Yet Recruiting

• 1 other identifier: pharous university cancer ptt
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cancer Cachexia; Sarcopenia

Keywords

cancer,sarcopenia,pt

Outcome Measures

Primary Outcomes (1)

• Changes in Serum Biomarkers of Muscle-Bone Crosstalk

  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 Outcomes (2)

• Change in Muscle Strength

  Baseline and 3 months post-intervention

• Change in Bone Mineral Density (BMD

  Baseline and 3 months post-intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

Structured Physical Therapy Exercise Program OTHER

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.

Also known as: Standard Care and Nutritional Support

Experimental Group; control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharos University in Alexandria: lead

MeSH Terms

Conditions

Sarcopenia; Neoplasms

Interventions

Standard of Care; Nutritional Support

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Nutrition Therapy; Therapeutics

Central Study Contacts

ola E elgohary, Lecturer

CONTACT

01227191398; ola.elgohary@pua.edu.eg

lamia S tolba, Lecturer

CONTACT

01007215433; lamiaa.said@pua.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the physical therapy exercise intervention, participants, care providers, and investigators cannot be blinded to group assignment. To minimize assessment bias, primary and secondary outcomes-including ELISA laboratory biomarker analyses, DEXA body composition scans, and functional performance tests (6MWT, TUG, SPPB)-will be evaluated by independent outcomes assessors who are kept blinded to participant group allocation throughout the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectuerer of physical therapy

Model Details: Participants will be randomly assigned to one of two parallel groups in a 1:1 ratio: an Experimental Group (receiving a structured 3-month physical therapy exercise protocol alongside neoadjuvant chemotherapy and nutritional support) or a Control Group (receiving standard neoadjuvant chemotherapy and nutritional support alone)

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): October 29, 2026
• Primary Completion (Estimated): January 28, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share