Clinical trial NCT06737692: Effects of Aerobic and Resistance Exercise Training in Individuals with Cancer Cachexia
Official title: Investigation of the Effects of Aerobic and Resistance Exercise Training in Individuals with Gastrointestinal Cancer and Cachexia: Randomized Controlled Single-Blind Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Cachexia (CC)
Keywords: exercise
cancer
cachexia
aerobic
resistance
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group. The study will be single-blind, meaning the Outcomes Assessor will not know which group the participants belong to.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.

A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.

Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:

Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.

The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks.

The intensity will be progressively adjusted based on the individual's perceived exertion.

Detailed description: Cancer cachexia is a multifactorial syndrome characterized by progressive functional impairment and loss of skeletal muscle mass, which does not improve with nutritional support. This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.

A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.

The study will be single-blind, meaning the outcome assessor will not know which group the participants belong to.

Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:

Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.

The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks.

Supervised Aerobic Exercises: Conducted every two weeks, three days a week. Supervised Resistance Exercises: Conducted every two weeks on consecutive days. On weeks without supervised exercises, participants will follow a home exercise program that includes breathing exercises, walking for 20-30 minutes, and resistance exercises.

The supervised aerobic exercises will consist of 20 minutes on a treadmill at a heart rate corresponding to 55-75% of the Karvonen formula. Warm-up and cool-down will be performed at 30-40% of the Karvonen heart rate for 5 minutes.

Resistance training will involve 12 different exercises targeting major muscle groups, using body weight and resistance bands, at an effort level of 5-7 on the Borg scale, with 8-12 repetitions and 1-3 sets.

The intensity will be progressively adjusted based on the individual's perceived exertion.

Eligibility criteria: Inclusion Criteria:

* Stage III-IV gastrointestinal cancer diagnosis
* Age 18-65
* Receiving systemic treatment (chemotherapy and/or targeted therapy and/or immunotherapy), at least 6 weeks after surgery,
* Karnofsky performance score 80 and above,
* Diagnosis of cachexia according to diagnostic criteria and Glasgow Prognostic Score (5,30) (\>5% weight loss in the last 6 months or \>2% weight loss in patients with BMI less than 20 kg/m2 or \>2% weight loss in sarcopenic individuals)

Exclusion Criteria:

* Musculoskeletal disorder
* Neurological disorder
* Severely impaired hematological capacity
* History of cardiac disease
* Uncontrolled hypertension
* Severe renal insufficiency
* Advanced osteoporosis
* Decreased ability to stand or walk

Primary outcomes:
measure: Evaluation of Demographic and Clinical Information
timeFrame: At baseline and after 12 weeks of exercise training
measure: Weight Assessment
timeFrame: At baseline and after 12 weeks of exercise training
measure: Height Assessment
timeFrame: At baseline and after 12 weeks of exercise training
measure: Body Mass Index Assessment Body Mass Index Assessment
timeFrame: At baseline and after 12 weeks of exercise training
measure: Assessment of Muscle Strength
timeFrame: At baseline and after 12 weeks of exercise training
measure: Assessment of Lower Extremity Performance
timeFrame: At baseline and after 12 weeks of exercise training
measure: Sarcopenia Assessments
timeFrame: At baseline and after 12 weeks of exercise training
measure: Assessment of Muscle and Fat Mass
timeFrame: At baseline and after 12 weeks of exercise training
measure: Mobility, balance and performance assessment
timeFrame: At baseline and after 12 weeks of exercise training
measure: Assessment of Functional Exercise Capacity
timeFrame: At baseline and after 12 weeks of exercise training
measure: Assessment of Gait Parameters
timeFrame: At baseline and after 12 weeks of exercise training
Secondary outcomes:
measure: Performance Assessment
timeFrame: At baseline and after 12 weeks of exercise training
measure: Evaluation of Symptoms
timeFrame: At baseline and after 12 weeks of exercise training
measure: Frailty Assessment
timeFrame: At baseline and after 12 weeks of exercise training
measure: Assessment of Cancer-Related Fatigue
timeFrame: At baseline and after 12 weeks of exercise training
measure: Assessment of Quality of Life
timeFrame: At baseline and after 12 weeks of exercise training
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
affiliation: Dokuz Eylul University, Faculty of Physical Therapy and Rehabilitation
name: Didem Karadibak, PhD
role: PRINCIPAL_INVESTIGATOR
References: