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Nutrition and Anabolic Interventions in Cancer Cachexia


Phase 1
18 Years
65 Years
Open (Enrolling)
Female
Cachexia, Cervical Cancer

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Trial Information

Nutrition and Anabolic Interventions in Cancer Cachexia


OBJECTIVES:

- To determine the effect of testosterone therapy on lean body mass and muscle strength
in patients with advanced or recurrent cervical carcinoma and cachexia.

- To determine the effect of testosterone therapy on muscle protein synthesis and
breakdown in patients with advanced or recurrent cervical carcinoma and cachexia.

- To determine the testosterone therapy on inflammatory biomarkers and signaling pathways
involved in the regulation of muscle atrophy in patients with advanced or recurrent
cervical carcinoma and cachexia.

OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo
testosterone intramuscularly (IM) weekly for 7 weeks.

- Arm II: Patients receive standard of care chemotherapy and/or radiation and
testosterone IM weekly for 7 weeks.

Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope
metabolic studies, MRI scan, indirect calorimetry studies, and assessment of their physical
activity level, and nutritional counseling. Patients also complete mood, fatigue, and
quality-of-life questionnaires.

Blood, muscle tissue, and saliva samples are collected periodically for laboratory studies.
Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by
immunoassay; (Atrogin-1) a muscle-specific F-box protein highly expressed during muscle
atrophy, Muscle-specific RING-finger protein 1(MuRF1), and ubiquitin expression by
quantitative real-time polymerase chain reaction(PCR); and Nuclear Factor-KappaB (NF-kB)
expression by western analysis.

After completion of study treatment, patients are followed periodically for 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent cervical carcinoma

- Weight loss of ≥ 10% within the past 6 months

- No ovarian tumors (e.g., Sertoli-Leydig cell tumor) or androgen-secreting tumors of
the ovary or adrenal gland

PATIENT CHARACTERISTICS:

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Mini Mental State Examination score > 23

- Not pregnant

- No evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver
enzymes

- No significant liver, renal, or heart disease

- No diabetes mellitus or other untreated endocrine disease

- No polycystic ovary syndrome and/or hyperthecosis

- No non-classical adrenal hyperplasia

- No Cushing's syndrome

- No glucocorticoid resistance

- No hyperprolactinoma or hypothyroidism

- No lactose intolerance

- No alcohol or drug abuse

- No other circumstance that would preclude study participation, in the opinion of the
principal investigator or study physician

PRIOR CONCURRENT THERAPY:

- More than 3 months since prior anabolic steroids

- No concurrent anticoagulant therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Total lean body mass and regional muscle mass as measured by dual energy x-ray absorptiometry (DEXA) and leg muscle volume as measured by MRI at baseline and 7 weeks.

Outcome Time Frame:

Baseline and 7 weeks

Safety Issue:

No

Principal Investigator

Melinda Sheffield-Moore, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas

Authority:

United States: Institutional Review Board

Study ID:

06-073

NCT ID:

NCT00878995

Start Date:

April 2008

Completion Date:

March 2015

Related Keywords:

  • Cachexia
  • Cervical Cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • recurrent cervical cancer
  • cachexia
  • Cachexia
  • Uterine Cervical Neoplasms

Name

Location
University of Texas Medical Branch Galveston, Texas  77555-1329