Strength Training on Pancreatic Cancer

NCT01395563 | Withdrawn DMC

• 1 other identifier: GermanCRC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED).

Conditions

Pancreatic Neoplasms; Cachexia; Myopathy

Outcome Measures

Primary Outcomes (1)

• muscle mass and strength

  after 8 weeks of intervention

Secondary Outcomes (1)

• quality of life

  after 8 weeks of intervention

Study Arms (2)

1

EXPERIMENTAL

pancreatic cancer patients

Behavioral: strength training

2

EXPERIMENTAL

pancreatic cancer patients

Behavioral: strength training

Interventions

strength training BEHAVIORAL

strength training, high intensity, twice up to 3 times per week

Also known as: progressive resistance training, sports, muscle hypertrophia, cachexia

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with pancreatic carcinomas after surgery (resection or exploration)
• given consent

You may not qualify if:

• acute infection
• pain
• no mobility or ability for walking or standing
• severe neurological disorders (apoplex, morbus Parkinson, paresis of the lower extremeties)
• severe cardiac or cardiovascular diseases (z.B. heart insufficiency NYHA III, myocardial infarction \<3 months)
• rhytmical disorders, that contraindicate ergospirometric examinations
• cardiac therapy with digitalis pharmacy
• unclear syncopes
• severe pulmonal insufficiency
• renal insufficiency (GFR \< 30% at Krea \>3 mg/dl)
• synchronous participation in an other clinical trial

Sponsors & Collaborators

• German Cancer Research Center: lead
• Heidelberg University: collaborator
• Technical University of Munich: collaborator

Study Sites (3)

European Pancreas Center

Heidelberg, 69120, Germany

Location

German Cancer Research Center

Heidelberg, 69120, Germany

Location

Technische Universität München

Munich, 81675, Germany

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Cachexia; Muscular Diseases

Interventions

Resistance Training; dermcidin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

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

• Jens Werner, Prof. Dr. med.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Holger Krakowski-Roosen, Dr.

  German CRC

  PRINCIPAL INVESTIGATOR

• Marc Martignoni, PD Dr. med.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: July 15, 2011
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 13, 2015

Record last verified: 2015-03

Locations

DE (3)