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

NCT05650827 | Active Not Recruiting

• 1 other identifier: 18.10.22
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastro-esophageal Cancer

Keywords

Exercise oncology; Resistance exercise; Cancer; Cancer cachexia; Protein supplements; Sarcopenia; Palliative chemotherapy

Outcome Measures

Primary Outcomes (3)

• Exercise feasibility: Exercise sessions attendance

  The number of attended exercise training sessions relative to the number of planed exercise sessions

  From baseline until end of intervention (10 weeks)

• Exercise feasibility: Relative dose-intensity of protein supplement

  The actual amount consumed relative to the amount prescribed over the intervention period

  From baseline until end of intervention (10 weeks)

• Incidence of Serious Adverse Events (SAEs).

  SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.

  Baseline until end of intervention (10 weeks)

Secondary Outcomes (53)

• Exercise feasibility: Relative dose intensity of exercise

  Baseline until end of intervention (10 weeks)

• Exercise feasibility: Early termination of exercise sessions

  Baseline until end of intervention (10 weeks)

• Exercise feasibility: Exercise intervention interruptions

  Baseline until end of intervention (10 weeks)

• Exercise feasibility: Permanent discontinuation

  Baseline until end of intervention (10 weeks)

• Body composition and anthropometrics: Total lean mass

  Baseline, end of week 10

Other Outcomes (24)

• Blood biochemistry: Leukocyte differential counts

  Baseline, end of week 10

• Blood biochemistry: C-reactive protein

  Baseline, end of week 10

• Blood biochemistry: albumin and protein

  Baseline, end of week 10

Study Arms (2)

Standard Care Control

NO INTERVENTION

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

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.

Behavioral: Resistance training; Dietary Supplement: Protein supplement

Interventions

Resistance training BEHAVIORAL

10 weeks of resistance training 3 times pr. week.

Exercise and protein supplements intervention group

Protein supplement DIETARY_SUPPLEMENT

A daily supplement of protein to ensure a daily intake of 1,6g protein/kg bodyweight

Exercise and protein supplements intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Casper Simonsen, PhD

  Copenhagen University Hospital, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 14, 2022
• Study Start: February 24, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)