Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy

NCT ID: NCT04065815

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-03-31

Brief Summary

This study aims to evaluate the effects of a 12-week protein-rich individualized nutritional therapy combined with different time-efficient exercise programs on overall physical fitness (cardiorespiratory fitness and muscular fitness), inflammation, and muscle mass/body composition in patients with malignant disease undergoing curative or palliative anti-cancer treatment

Conditions

Cancer; Cancer Cachexia; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resistance Training (RT)

Individualized, protein-rich nutritional therapy combined with resistance training

Group Type: EXPERIMENTAL

Resistance Training

Intervention Type: OTHER

Conventional Resistance Training:

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a resistance training program consisting of five exercises: exercises (chest, upper/lower back, abdominals, legs)

• 1 set per exercise
• time-effort per session: ~20 min
• 2 training sessions per week

WB-EMS

Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS)

Group Type: EXPERIMENTAL

WB-EMS

Intervention Type: OTHER

Whole-Body Electromyostimulation (WB-EMS):

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with WB-EMS training:

• Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; patients perform simple exercises during the stimulation period following a video tutorial
• time-effort per session: ~20 min
• 2 training sessions per week

High-intensity interval training (HIIT)

Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)

Group Type: EXPERIMENTAL

High-intensity interval training (HIIT)

Intervention Type: OTHER

HIIT:

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with high-intensity interval training (HIIT):

• supervised cycle-ergometer training at at 80-95% HRmax
• time-effort per session: ~15 min
• 2 training sessions per week

Combined HIIT and Resistance Training (Combi)

Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training

Group Type: EXPERIMENTAL

Combined HIIT and Resistance Training (Combi)

Intervention Type: OTHER

HIIT combined with conventional Resistance Training:

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a combined HIIT and resistance training program:

HIIT:

• supervised cycle-ergometer training at at 80-95% HRmax
• time-effort per session: ~15 min
• 1 training session per week

Resistance Training:

• five exercises: exercises (chest, upper/lower back, abdominals, legs)
• 1 set per exercise
• time-effort per session: ~20 min
• 1 training session per week

Interventions

Resistance Training

Conventional Resistance Training:

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a resistance training program consisting of five exercises: exercises (chest, upper/lower back, abdominals, legs)

• 1 set per exercise
• time-effort per session: ~20 min
• 2 training sessions per week

Intervention Type: OTHER

WB-EMS

Whole-Body Electromyostimulation (WB-EMS):

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with WB-EMS training:

• Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; patients perform simple exercises during the stimulation period following a video tutorial
• time-effort per session: ~20 min
• 2 training sessions per week

Intervention Type: OTHER

High-intensity interval training (HIIT)

HIIT:

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with high-intensity interval training (HIIT):

• supervised cycle-ergometer training at at 80-95% HRmax
• time-effort per session: ~15 min
• 2 training sessions per week

Intervention Type: OTHER

Combined HIIT and Resistance Training (Combi)

HIIT combined with conventional Resistance Training:

Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a combined HIIT and resistance training program:

HIIT:

• supervised cycle-ergometer training at at 80-95% HRmax
• time-effort per session: ~15 min
• 1 training session per week

Resistance Training:

• five exercises: exercises (chest, upper/lower back, abdominals, legs)
• 1 set per exercise
• time-effort per session: ~20 min
• 1 training session per week

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
• ongoing or planned curative or palliative anti-cancer therapy
• ECOG-Status 0-2

Exclusion Criteria

• simultaneous participation in other nutritional or exercise intervention Trials
• bone metastases with high fracture risk
• cardiovascular disease
• use of anabolic medications
• epilepsy
• severe neurological or rheumatic diseases
• skin lesions in the area of electrodes
• energy active metals in body
• pregnancy
• acute vein thrombosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dejan Reljic, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Yurdagül Zopf, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Locations

Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports

Erlangen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Hans Joachim Herrmann, Dr.

Role: CONTACT

hans.herrmann@uk-erlangen.de

+49 9131 8545218

Yurdagül Zopf, Prof.

Role: CONTACT

yurdaguel.zopf@uk-erlangen.de

+49 9131 8545218

Facility Contacts

Hans Joachim Herrmann, Dr.

Role: primary

hans.herrmann@uk-erlangen.de

+49 9131 8545218

Dejan Reljic, Dr.

Role: backup

dejan.reljic@uk-erlangen.de

+49 9131 8545218

References

Reljic D, Herrmann HJ, Jakobs B, Dieterich W, Mougiakakos D, Neurath MF, Zopf Y. Feasibility, Safety, and Preliminary Efficacy of Very Low-Volume Interval Training in Advanced Cancer Patients. Med Sci Sports Exerc. 2022 Nov 1;54(11):1817-1830. doi: 10.1249/MSS.0000000000002989. Epub 2022 Jul 8.

Reference Type: DERIVED

PMID: 35868017 (View on PubMed)

Other Identifiers

PROTECT-Study

Identifier Type: -

Identifier Source: org_study_id