A Pilot study for Exercise and Nutrition Intervention for Cancer Patients with low muscle mass during chemotherapy

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0009224

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1) Age 19 or older
2) Patients with histologically confirmed solid cancer
3) Planned or receiving palliative chemotherapy or neoadjuvant/adjuvant chemotherapy using two or more cytotoxic chemotherapy agents
4) ECOG performance status 0-2
5) If a basal abdominal CT (contrast CT must include the portal phase) that can confirm sarcopenia was taken within 4 weeks of participating in the study.
6) Class I or class II sarcopenia with skeletal muscle index (=skeletal muscle area / BMI) T-score less than -1.0 measured by CT
7) Life expectancy of more than 3 months
8) Patients who can understand the research subject consent document and are willing to sign it

Exclusion Criteria

1) Cases where there is a high risk of injury or fall during exercise intervention, such as bone metastasis, peripheral neuropathy, brain metastasis, etc.
2) Cases where it is difficult to follow the exercise intervention of the mobile application due to cognitive decline, illiteracy, or severe hearing and vision impairment.
3) If you do not have a smartphone
4) Cases where protein intake is limited due to decreased renal function (eGFR <50mL/min/1.73m2)
5) When the researcher determines that exercise and nutritional intervention are not best for the patient due to other clinical conditions.
6) Over 80 years old

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SMI (skeletal muscle index) T-score assessed by CT

Secondary Outcome Measures

Name	Time	Method
Myosteatosis index assessed by CT (NAMA/TAMA index T-score) *NAMA (normal-attenuation muscle area), TAMA (total abdominal muscle area);Skeletal muscle mass, fat mass, lean body mass (kg/m2) evaluated by BIA (Bioelectrical Impedance Analysis);Body Mass Index (kg/m2) , Ht, weight, waist circumference;Nutritional assessment using MNA-SF (Mini Nutritional Assessment-Short Form);Exercise evaluation using SPBB (short physical performance battery);Hand grip strength (kg) ;(health-related quality of life; EORTC-QLQ-C30);Compliance to exercise and nutrition interventions (%);Progression-free survival (calculated separately for metastatic and non-metastatic cancer);Overall survival (calculated separately for metastatic and non-metastatic cancer);Blood test results (CRP, LD, CBC, t-chol, albumin); Incidence, nature and severity of adverse events with severity (Safety profile) - Common Terminology Criteria for Adverse Events (CTCAE) v5.0