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

Rigshospitalet

Status: Active, not recruiting

Conditions: Gastro-esophageal Cancer

Treatments: Dietary Supplement: Protein supplement; Behavioral: Resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT05650827

18.10.22

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction
• referred to first line chemotherapy.

Exclusion criteria

• Age < 18
• Living outside the greater Copenhagen area
• Any other malignancy requiring active treatment
• Not eligible for chemotherapy
• Performance status > 2
• Not able to swallow liquids
• Parenteral nutrition or enteral nutrition via feeding tube
• Physical or mental disabilities that prohibit execution of test or training procedures
• Pregnancy
• Inability to understand the Danish language

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Standard Care Control

No Intervention group

Description:

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.

Exercise and protein supplements intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Resistance training

Dietary Supplement: Protein supplement