Gastrointestinal NeoplasmsPhase 2NCT00196885
Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training
A Phase 2 study testing N-acetylcysteine in people with Gastrointestinal Neoplasms and Bronchial Carcinoma, run by German Cancer Research Center at 1 site in Germany.
Trial summary
The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a thiol-antioxidant)improves the exercise training effect on cancer patients that experience weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Neoplasms, Bronchial Carcinoma, Hodgkin Disease
- What is being tested?
- N-acetylcysteine
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2003to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- gastrointestinal or bronchial cancer
- weight loss of 10% within 6 months
- sufficient mobility
Who cannot join
- severe pain, steroid therapy, severe internal, muscular, neurological, psychiatric disease, N-acetylcysteine allergy
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Cancer Research Center, D020
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)
The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a thiol-antioxidant)improves the exercise training effect on cancer patients that experience weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.
- Conditions
- Gastrointestinal Neoplasms, Bronchial Carcinoma, Hodgkin Disease, Non-Hodgkin Lymphoma, Weight Loss
- Being tested
- N-acetylcysteine
- Keywords
- cancer cachexia, muscle wasting, weight loss, proteolysis
- Medical subject headings
- Gastrointestinal Neoplasms, Carcinoma, Bronchogenic, Hodgkin Disease, Lymphoma, Non-Hodgkin, Weight Loss, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle cross-sectional area, peak forces
Secondary outcomes (2)
muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
muscle 31Phospho-magnetic-resonance spectroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Investigators
- Wulf Hildebrandt, MD, Study director, German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196885
- Sponsor's protocol ID
- whilde157/2003
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 20 Jun 2008
- Results posted
- No
Publications
Hauer K, Hildebrandt W, Sehl Y, Edler L, Oster P, Droge W. Improvement in muscular performance and decrease in tumor necrosis factor level in old age after antioxidant treatment. J Mol Med (Berl). 2003 Feb;81(2):118-25. doi: 10.1007/s00109-002-0406-7. Epub 2003 Feb 8.
PubMed 12601528
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)
- ClinicalTrials.gov ID
- NCT00196885
- Acronym / sponsor ID
- whilde157/2003
- Conditions
- Gastrointestinal Neoplasms, Bronchial Carcinoma, Hodgkin Disease, Non-Hodgkin Lymphoma, Weight Loss
- Keywords
- cancer cachexia, muscle wasting, weight loss, proteolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Dec 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a thiol-antioxidant)improves the exercise training effect on cancer patients that experience weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- gastrointestinal or bronchial cancer
- weight loss of 10% within 6 months
- sufficient mobility
Key exclusion criteria (1 listed)
- severe pain, steroid therapy, severe internal, muscular, neurological, psychiatric disease, N-acetylcysteine allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine | Drug | – |
Primary outcome
muscle cross-sectional area, peak forces
2 secondary outcomes
muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
muscle 31Phospho-magnetic-resonance spectroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
- Background: PubMed 12601528Hauer K, Hildebrandt W, Sehl Y, Edler L, Oster P, Droge W. Improvement in muscular performance and decrease in tumor necrosis factor level in old age after antioxidant treatment. J Mol Med (Berl). 2003 Feb;81(2):118-25. doi: 10.1007/s00109-002-0406-7. Epub 2003 Feb 8.
Related trials for Gastrointestinal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wulf Hildebrandt, MD study director
German Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Gastrointestinal Neoplasms and Bronchial Carcinoma, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle cross-sectional area, peak forces. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2008.