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

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Inflammation; Cancer Cachexia; Cancer

Treatments: Other: High-intensity interval training (HIIT); Other: WB-EMS; Other: Combined HIIT and Resistance Training (Combi); Other: Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04065815

PROTECT-Study

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Resistance Training (RT)

Experimental group

Description:

Individualized, protein-rich nutritional therapy combined with resistance training

Treatment:

Other: Resistance Training

WB-EMS

Experimental group

Description:

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

Treatment:

Other: WB-EMS

High-intensity interval training (HIIT)

Experimental group

Description:

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

Treatment:

Other: High-intensity interval training (HIIT)

Combined HIIT and Resistance Training (Combi)

Experimental group

Description:

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

Treatment:

Other: Combined HIIT and Resistance Training (Combi)