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A Randomized, Double-Blind, Pilot Study Comparing the Safety and Efficacy of Betamarc Plus Chemotherapy to Chemotherapy Alone in the Prevention and Treatment of CACS in Patients With Advanced NSCLC


Phase 2
18 Years
N/A
Not Enrolling
Both
Anorexia, Cachexia, Weight Loss, Carcinoma, Non-Small-Cell Lung

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Trial Information

A Randomized, Double-Blind, Pilot Study Comparing the Safety and Efficacy of Betamarc Plus Chemotherapy to Chemotherapy Alone in the Prevention and Treatment of CACS in Patients With Advanced NSCLC


Inclusion Criteria:



- Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after
resection for earlier stage disease is acceptable as long as patients are at least 6
months from surgery.

- Treatment plan includes a platinum-based doublet chemotherapy.

- ECOG 0, 1 or 2.

- Self-reported loss of body weight or anorexia.

- Serum C-reactive protein ≥5 mg/L.

- Life expectancy of at least 6 months.

- Adequate bone marrow, liver and renal function.

- Normal serum potassium.

- Ability to comply with the study requirements and give written informed consent.

Exclusion Criteria:

- Known physical or functional obstruction of the gastrointestinal tract,
malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving
tube feeding or parenteral nutrition, or unable to swallow investigational drug
product.

- Concomitant therapy with an appetite stimulant.

- History of poorly controlled hypertension or congestive heart failure.

- Any implanted devices that could interfere with DXA scanning.

- Prolongation of QT interval.

- History of additional risk factors for torsades de pointe.

- Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or
ergot derivatives.

- Females who are breast feeding, pregnant or of child-bearing potential who are not
using adequate birth control.

- Any second malignancy which might confound the interpretation of safety or efficacy
assessments.

- Any condition which increases the patient's risk for participating in the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate

Outcome Time Frame:

25 weeks

Safety Issue:

No

Principal Investigator

Yung-chuan Sung

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cathay General Hospital

Authority:

Taiwan: Department of Health

Study ID:

ANA-CTP0002

NCT ID:

NCT00535015

Start Date:

October 2007

Completion Date:

August 2008

Related Keywords:

  • Anorexia
  • Cachexia
  • Weight Loss
  • Carcinoma, Non-Small-Cell Lung
  • Anorexia
  • Cachexia
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Weight Loss

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