Rectal Cancer Clinical Trial
— MExOfficial title:
Mitochondria Preservation by Exercise Training: A Targeted Therapy for Cancer and Chemotherapy-induced Cachexia.
Verified date | September 2021 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to define the contribution of cancer and chemotherapy to muscle and systemic alterations that drive the onset of cachexia in rectal cancer patients and validate in human cancer cachexia (CC) the alterations in mitochondrial function and neuromuscular junction (NMJ) observed in the experimental models, thus providing the rationale for potential anti-cachexia strategies based on exercise and or exercise mimetics.
Status | Enrolling by invitation |
Enrollment | 144 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients with confirmed histopathological diagnosis of rectal adenocarcinoma ycTNM stage II, III, or IV (AJCC 8th). - Patients treated with neoadjuvant therapy. - Patients that will be subject to curative intent or palliative surgery through any approach (open, laparoscopic, or robotic). - Ability to sign the informed consent. Exclusion Criteria: - Rectal cancer stage I or any stage without neoadjuvant therapy. - Age < 18 and >75 years - Long steroid treatment for any cause. - Emergency setting. - Co-existent inflammatory bowel disease. - Inflammatory comorbidities (liver failure, diabetes, metabolic acidosis, acute and chronic renal failure, sepsis, AIDS, acute and chronic hepatitis, autoimmune disorders, and chronic obstructive pulmonary disease). - Healthy volunteers. - Other (simultaneous) neoplastic disease |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Luigi Gonzaga | Orbassano | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy | Catholic University of the Sacred Heart, University of Padova, University of Roma La Sapienza |
Italy,
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Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical function | Determinate by the short physical performance battery (SPPB) Score, a series of tests used to evaluate lower extremity function and mobility in older people. Scores are assigned according to performance, with an overall maximum score of 12. A cut off score < 10 indicates mobility disability and cut point: = 8 points for diagnosing of severe sarcopenia | Preoperative. | |
Primary | Physical activity-Subjective Measurement | Determinate by the physical activity scale for the elderly (PASE) Score, the overall score ranging from 0 to 793, higher scores indicated greater physical activity | Preoperative | |
Primary | Physical activity-Objective Measurement (step count) | Determinate by the average daily step count (total number of steps/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days. | Preoperative. | |
Primary | Physical activity-Objective Measurement (sleep) | Determinate by the average of daily sleep duration(total minutes of sleep/ 14 days) recorded by wearing a Smart Watch for two weeks on consecutive days. | Preoperative. | |
Primary | Physical activity-Objective Measurement (sedentary time) | Determinate by the average daily sedentary time (total minutes of inactivity/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days. | Preoperative. | |
Primary | Physical activity-Objective Measurement (active time) | Determinate by the average daily active time (total duration of activity in minutes/14 days) recorded by wearing a Smart Watch for two weeks on consecutive days. | Preoperative. | |
Primary | Muscular quantity | Determinate by the Skeletal muscle index (SMI) = skeletal muscle area or cross-sectional area at L4-L5 (cm2)/height2(m2) from the preoperative magnetic resonance imaging. | Preoperative. | |
Primary | Muscular quality (muscle fat content) by magnetic resonance imaging | Determinate by the proton density fat fraction (PDFF) of paraspinal muscles at L4-L5 | Preoperative. | |
Primary | Nutritional status - Albumin | Blood levels of albumin (g/dL). | Preoperative. | |
Primary | Nutritional status - Prealbumin | Blood levels of prealbumin(mg/dL). | Preoperative. | |
Primary | Nutritional status - transferrin | Blood levels of transferrin(mg/dL). | Preoperative. | |
Primary | General health marker- hemoglobin | Blood levels of Hemoglobin (g/L). | Preoperative. | |
Primary | Inflammatory status-White blood cells count | White blood cells count (10^/L). | Preoperative. | |
Primary | Inflammatory status - C-reactive protein | Blood levels of C-reactive protein (mg/dL). | Preoperative. | |
Primary | Muscle wasting- creatine kinase | Blood levels of creatine kinase (U/L). | Preoperative. | |
Primary | Morphometric analysis of skeletal muscle | Description of the dimension and type of muscular fibers from an abdominal wall muscle biopsy harvested intraoperatively. | within 30 postoperative days. | |
Primary | Molecular analysis of skeletal muscle | Characterization of molecular signatures associated with Neo-adjuvant Chemotherapy and rectal cancer by comparing molecular profiles of a muscular biopsies harvested intraoperatively. | within 60 postoperative days. | |
Primary | Muscle protein metabolism | Muscle-specific ubiquitin-ligases expression, mitophagy cargo shuttle, fusion-fission machinery, and mitochondrial biogenesis will be assayed from a muscular biopsy harvested intraoperatively. | within 60 postoperative days. | |
Secondary | Overall survival | to describe the percentage of participants who are alive three years after surgery | 3 years after surgery. |
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