Nervous System Diseases

Symptoms and General Pathology

All Conditions

Infections

Sarcopenia

Communicable Diseases

Postoperative Complications

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Herbal and Botanical

All Drugs and Chemicals

Cola

The usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity

In addition to the usual pre-surgical preparation and conditioning, a nutritional supplement and increased physical activity will be provided in a controlled manner for 3 weeks.

One líquid brick every day during 3 weeks

Protein supplement

Ricardo Frago, Ph D

The sarcopenia is a new concept for evaluating the functional status of patients, introduced during the last 20 years. This is defined as the relationship between the deterioration of muscle mass and the decrease in strength, the metabolic rate, the aerobic capacity and subsequently the evaluation of the functional status. The sarcopenia has been estimated to affect 5% to 13% of people aged between 60 and 70 years, increasing from 11% to 50% in those aged 80 years and older. In a study by Lieffers et al. of a total of 234 patients with colorectal cancer, with a mean age of 63 years according to the values observed by Prado et al., the prevalence of sarcopenia would be around 39%, being able to reach up to 60% in patients with chronic diseases.

The goal of this study is to compare the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise.

CONCEPTUAL HYPOTHESIS Improving functional status through physical exercise and nutritional supplementation of sarcopenic colon cancer patients at diagnosis can reduce the rate of infectious complications after surgery.

OPERATIONAL HYPOTHESIS Active preoperative preparation of sarcopenic colon cancer patients reduces post-surgical infectious complications by at least 11%, reaching a rate similar to patients without initial sarcopenia.

Inclusion criteria: - Age ≥ 70 years old; - Colon adenocarcinoma without synchronous metastases; - No urgent surgery; - ECOG performance status ≤ 2 .; - no pregnancy or lactation .; - signature of the informed consent; - ability to comply with the study indications. Exclusion criteria: - rectal cancer; - Concomitant neoplastic disease in the last 5 years - medical or mental condition of the patient that compromises the authorization of informed consent; - Concomitant uncontrolled or stable medical condition; - Clinically significant heart disease (congestive heart failure, symptomatic coronary disease) - Refusal to participate in the study.

Study variable (categorization of patients): Evaluation of Sarcopenia: it will be performed by CT, identifying the image of L3 (3rd lumbar vertebra). Main outcome variable: Cumulative incidence of post-surgical complications due to infection at 30 days.

Secondary variables: Frailty, Immune status, Quality of life (QoL) C30 and CR29 INTRVENTION (study groups)

* ARM A (Control: No sarcopenia): the usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity.
* ARM B (Experimental: Sarcopenia): in addition to the usual pre-surgical preparation and conditioning, a nutritional supplement and increased physical activity will be provided in a controlled manner for 3 weeks.

Sarcopenia in Colorectal Cancer Patients, Intervention Study

Intervention, Non-randomized Controlled, Non-masked and Comparative Study of Presurgical Conditioning in Colorectal Cancer Patients Who Present With Sarcopenia

Evaluate the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise in the latter group

To study survival one year after surgery in patients considered preoperatively as having sarcopenia.

Evaluate the quality of life according the QLQ EORTC QlQ C-30 y ClQ CR29

Hospital Universitari de Bellvitge

Nutritional and Metabolic Diseases

Malnutrition

Nutrition Disorders

This group will receive dietary guidance and protein supplements for 3 months

this group will receive dietary guidance for 3 months

protein supplement

nutrition counseling for guidance of food intake

nutrition counseling

Kang Yu, MD

Fang Wang, MD

Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. The current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.

An anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be used in statistical analysis.

the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition

blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)

nutritional risk based on nutrition risk screening-2002 (NRS-2002)

malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)

phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA)

Peking Union Medical College Hospital

Neoplasms

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Wasting Syndrome

Cachexia

Esophageal Cancer

Participants allocated to control receive first line chemotherapy the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark.

Participants allocated to control are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program. There will be no diet restrictions.

Participants allocated to intervention receive first line chemotherapy and the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark.

The intervention consists of resistance training and a daily protein supplement.

10 weeks of resistance training 3 times pr. week.

Resistance training

A daily supplement of protein to ensure a daily intake of 1,6g protein/kg bodyweight

Rikke Krabek, MD

Rikke Krabek

Casper Simonsen, PhD

Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death.

Resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. Therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy.

A total of 54 patients with advanced gastroesophageal cancer will be recruited from the Department of Oncology, Copenhagen University Hospital, Rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.

Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

Changes in differential counts (total and per type: eosinofils, basofils, neutrofils, monocytes and lymphocytes)

Changes in low-density lipoprotein cholesterol

Changes in high-density lipoprotein cholesterol

Changes in glucose tolerance (2-hpur oral glucose tolerance test)

Muscle glucose uptake during insulin stimulation after acute exercise

Muscle protein synthesis during insulin stimulation after acute exercise.

Modifications of proteins after acute exercise. Muscle biopsies will be subjected to mass spectrometry-based proteomic analysis.

Modifications of mithochondrial regulation. Signaling of mitochondiral fission, fusion and mitophagy will be examined in mucle biopsies.

The number of attended exercise training sessions relative to the number of planed exercise sessions

The actual amount consumed relative to the amount prescribed over the intervention period

SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.

The actual dose relative to the prescribed minimum dose

Termination of an exercise session before the prescribed exercises have been performed

Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session

Incidence of permanent withdrawal from the intervention before intervention period has ended.

Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)

Changes in appendicular lean mass, assessed by DXA

Changes in total fat mass, assessed by DXA

Changes in fat percentage, assessed by DXA

Changes in bone mineral density, assessed by DXA

Changes in thickness of the vastus lateralis, assessed by ultrasound

Changes in skeletal muscle index, assessed by diagnostic CT scans

Changes in skeletal muscle attenuation, assessed by diagnostic CT scans

Changes in adipose tissue index, assessed by diagnostic CT scans

Changes in leg press one repetition maximum (1RM)

Changes in hand grip strength, assessed using a dynamometer

Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization

Proportion of patients who have not died 1 and 2 years after randomization

Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)

Treatment tolerance assessed by the delivery of chemotherapy (number of series recieved)

Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)

Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)

Response to chemotherapy assessed by Response Evaluation Criteria in Solid Tumors 1.1 (complete response, partiel response, stable disease, progressive disease)

Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) (scale-scoring 0-28, the higher the score the better quality of life)

Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)

Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-24, the higher the score the better quality of life)

Changes in patient-reported functional well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)

Changes in patient-reported gastroesophageal cancer specific well-being assessed using FACT-E (scale-scoring 0-68, the higher the score the better quality of life)

Changes in patient-reported cancer cachexia specific well-being assessed using Functional Assessment of Cancer Therapy - Cancer Cachexia (scale-scoring 0-48, the higher the score the better quality of life)

Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition)

Changes in patient-reported anxiety, assessed using the HADS (scale scoring: 0-21, the higher the score the worse the condition)

Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)

Changes in patient-reported weekly duration of moderate intensity PA, assessed using the IPAQ

Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the IPAQ

Changes in patient-reported weekly duration of total PA, assessed using the IPAQ (Expressed as metabolic equivalent (MET)-min per week: MET level x minutes of activity x events per week)

Changes in patient-reported weekly duration of sitting time, assessed using the IPAQ

Changes in patient-reported signs of sarcopenia, assessed using The Strength, assistance in walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire (scale scoring: 0-10, the higher the score the better the condition)

Changes in patient-reported three-day record of dietary intake assessed using questionnaries.

Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sarcopenia in Colorectal Cancer Patients, Intervention Study	NCT05491434	Sarcopenia Postoperative C... Infection;Post ...	Protein supplem...	70 Years -	Hospital Universitari de Bellvitge
the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition	NCT05802381	Cancer Malnutrition	protein supplem... nutrition couns...	18 Years -	Peking Union Medical College Hospital
Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer	NCT05650827	Gastro-esophage...	Resistance trai... Protein supplem...	18 Years -	Rigshospitalet, Denmark

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