Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID05307367

Identifying Molecular Factors Contributing to Cancer-associated Muscle Mass Loss and Providing Clinical Evidence for Exercise Mechanisms to Functionally Restore Muscle in Cancer

Led by University of Copenhagen · Updated on 2022-05-16

144

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

U

University of Copenhagen

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Muscle mass loss is a common and serious problem in people with cancer, especially in those with metastatic lung cancer. This condition, called cancer cachexia, involves involuntary weight loss and affects up to 80% of such patients. Researchers are investigating the molecular causes of muscle and fat loss, hormone sensitivity, and the role of exercise in potentially restoring muscle function and improving quality of life for both patients and their caregivers. The study aims to fill important gaps in knowledge about cancer cachexia and its impact on health and survival. The study includes three parts: first, examining hormone sensitivity and physical performance in patients with lung cancer undergoing their first type of cancer treatment; second, analyzing changes in muscle, fat, and blood samples to understand disease progression; and third, testing an exercise program involving supervised single-leg kicking training for 8 weeks to see if it can improve muscle signaling and function. Control subjects matched for age, weight, gender, and activity level will also participate in the exercise intervention. Participants will undergo assessments including muscle mass and disease outcome measurements after 12 weeks, insulin sensitivity testing at 8 weeks, and surveys on quality of life. Muscle and tissue samples will be collected to study molecular changes. The study will monitor physical function, hormone sensitivity, and patient-reported outcomes to understand the effects of cancer and exercise over time. Total participation duration varies with study parts but includes multiple visits for testing and training sessions.

CONDITIONS

Brief Title

Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 years or older
  • Diagnosed with histologically and radiologically confirmed non-small cell lung cancer (NSCLC) stage IIIb or IV
  • Not eligible for concurrent chemo/radiation therapy as primary treatment (WP1 and WP2)
  • Referred for first-line palliative anticancer therapy (platin-based, immunotherapy, combined therapy, or TKI) for WP1 and WP2
  • Referred for palliative anticancer therapy for recurrent cancer (WP2X)
  • Have a staging or baseline CT or PET/CT scan within 4 weeks before starting treatment or planned within the first week of treatment
  • ECOG Performance Status between 0 and 2
  • Have signed the informed consent form
Not Eligible

You will not qualify if you...

  • Any other active malignancy requiring treatment (previous cancer treatment completed is allowed)
  • Receiving local palliative radiotherapy as primary treatment
  • ECOG Performance Status greater than 2
  • Physical disabilities that prevent physical testing
  • Inability to understand Danish language
  • Inability to comprehend scoring systems or patient-reported outcome measures

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants undergo an 8-week supervised exercise training intervention involving single-leg kicking at 60-70% peak workload, 2 to 5 days per week for about 1 hour per session.

Multiple supervised exercise sessions weekly

Follow-up

Duration - Up to 12 weeks

Participants are monitored for disease outcome, muscle mass, proteomic changes, insulin sensitivity, and quality of life for up to 12 weeks from baseline.

Assessments at baseline and periodic follow-ups

Trial Site Locations

Total: 1 location

1

University of Copenhagen

Copenhagen, DK, Denmark, 2100

Actively Recruiting

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Research Team

J

Jonas Sørensen, MD.

L

Lykke Sylow, Ass.proff

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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