Targeting Muscle-Bone Crosstalk Through Physical Therapy in Cancer Cachexia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharos University in Alexandria
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Disqualifiers
Evidence of distant tumor metastasis (Grade 4 cancer).
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Physical Therapy Exercise Program
Other interventionExperimental 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
3 monthSecondary outcomes
1
Change in Muscle Strength
Measured using a hand-grip dynamomete
Time frame
Baseline and 3 months post-intervention2
Change in Bone Mineral Density (BMD
Measured using DEXA scan at the lumbar spine
Time frame
Baseline and 3 months post-interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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