Cancer CachexiaPU-PTCCNCT07807306
Targeting Muscle-Bone Crosstalk Through Physical Therapy in Cancer Cachexia
A study testing Structured Physical Therapy Exercise Program in people with Cancer Cachexia and Sarcopenia, run by Pharos University in Alexandria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia, Sarcopenia
- What is being tested?
- Structured Physical Therapy Exercise Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2026to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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)
- Conditions
- Cancer Cachexia, Sarcopenia
- Being tested
- Structured Physical Therapy Exercise Program
- Keywords
- cancer,sarcopenia,pt
- Medical subject headings
- Sarcopenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Physical Therapy Exercise ProgramOther
Also called Standard Care and Nutritional Support
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Structured Physical Therapy Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (2)
Change in Muscle Strength
Measured using a hand-grip dynamomete
Measured: Baseline and 3 months post-intervention
Change in Bone Mineral Density (BMD
Measured using DEXA scan at the lumbar spine
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start29 Oct 2026 (estimated)
- Primary completion28 Jan 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807306
- Sponsor's protocol ID
- pharous university cancer ptt
- Acronym
- PU-PTCC
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect patient confidentiality and clinical privacy.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Muscle-Bone Crosstalk: The Potential of Physical Therapy in Managing Cancer-Induced Cachexia
- ClinicalTrials.gov ID
- NCT07807306
- Acronym / sponsor ID
- PU-PTCC / pharous university cancer ptt
- Conditions
- Cancer Cachexia, Sarcopenia
- Keywords
- cancer,sarcopenia,pt
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Structured Physical Therapy Exercise ProgramParticipants 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. |
| control group | Placebo comparator | Other: Structured Physical Therapy Exercise ProgramParticipants receive standard neoadjuvant chemotherapy accompanied by standard nutritional support following cachexia onset, without participating in the structured physical therapy program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Physical Therapy Exercise ProgramAlso: Standard Care and Nutritional SupportExperimental 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 | Experimental Group, control group |
Primary outcome
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.
2 secondary outcomes
Change in Muscle Strength
Time frame: Baseline and 3 months post-intervention
Change in Bone Mineral Density (BMD
Time frame: Baseline and 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect patient confidentiality and clinical privacy.
Related trials for Cancer Cachexia
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
RecruitingPhase 2/3
Visugromab in Cachexia International Trial
Cancer-associated Cachexia
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Physical Therapy Exercise Program in people with Cancer Cachexia and Sarcopenia, run by Pharos University in Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ola E elgohary, Lecturer (01227191398, ola.elgohary@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Serum Biomarkers of Muscle-Bone Crosstalk (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.