このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年9月1日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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)

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：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.

他の名前：
  • Standard Care and Nutritional Support
プラセボコンパレーター：control group
Participants receive standard neoadjuvant chemotherapy accompanied by standard nutritional support following cachexia onset, without participating in the structured physical therapy program
他の：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.

他の名前：
  • Standard Care and Nutritional Support

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Changes in Serum Biomarkers of Muscle-Bone Crosstalk
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Muscle Strength
時間枠：Baseline and 3 months post-intervention
Measured using a hand-grip dynamomete
Baseline and 3 months post-intervention
Change in Bone Mineral Density (BMD
時間枠：Baseline and 3 months post-intervention
Measured using DEXA scan at the lumbar spine
Baseline and 3 months post-intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pharos University in Alexandria

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月29日

一次修了 (推定)

2027年1月28日

研究の完了 (推定)

2027年2月2日

試験登録日

最初に提出

2026年8月27日

QC基準を満たした最初の提出物

2026年9月1日

最初の投稿 (実際)

2026年9月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月8日

QC基準を満たした最後の更新が送信されました

2026年9月1日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • pharous university cancer ptt

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する