Clinical trial NCT00878995: Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Official title: Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cachexia
Squamous Cell Carcinoma
Keywords: stage IIB cervical cancer
stage III cervical cancer
recurrent cervical cancer
cachexia
advanced head/neck carcinoma
recurrent head/neck carcinoma
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-09
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in patients with cachexia caused by cancer.

PURPOSE: This randomized phase I trial is studying whether testosterone administered during standard of care chemotherapy and/or radiation works by helping patients with squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.

Detailed description: OBJECTIVES:

* To determine the effect of testosterone therapy on lean body mass and muscle strength in patients with advanced or recurrent squamous cell carcinoma.
* To determine the testosterone therapy on inflammatory biomarkers in patients with advanced or recurrent squamous cell carcinoma.

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, 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 urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay.

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

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Mini Mental State Examination score \> 23

Exclusion Criteria:

* Pregnancy
* Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes
* Significant liver, renal, or heart disease
* Diabetes mellitus or other untreated endocrine disease
* Polycystic ovary syndrome and/or hyperthecosis
* Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g., Sertoli- Leydig cell tumor)
* Non-classical adrenal hyperplasia
* Cushing's syndrome
* Glucocorticoid resistance
* Hyperprolactinoma or hypothyroidism
* Lactose intolerance
* Alcohol or drug abuse
* Recent treatment (within 3 months) with anabolic steroids
* Ongoing anticoagulant therapy
* Any other circumstance that would preclude study participation, in the opinion of the principal investigator or study physician

Primary outcomes:
measure: Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.
timeFrame: 7 weeks
Secondary outcomes:
measure: Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline
timeFrame: Baseline
measure: Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.
timeFrame: 7 weeks
measure: Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.
timeFrame: Baseline
measure: Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks
timeFrame: 7 weeks
measure: Body Weight as Measured by Scale at Baseline
timeFrame: Baseline
measure: Body Weight as Measured by Scale at 7 Weeks.
timeFrame: 7 weeks
measure: Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline
timeFrame: Baseline
measure: Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks
timeFrame: 7 weeks
measure: Physical Activity Levels as Measured by the ActiGraph Accelerometer
timeFrame: through study completion,up to 7 weeks
measure: Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline
timeFrame: Baseline
measure: Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks
timeFrame: 7 weeks
measure: Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.
timeFrame: baseline
measure: Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.
timeFrame: Baseline
measure: Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.
timeFrame: baseline
measure: Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.
timeFrame: baseline
measure: Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.
timeFrame: Baseline
measure: Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.
timeFrame: baseline
measure: Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.
timeFrame: Baseline
measure: Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.
timeFrame: Baseline
measure: Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.
timeFrame: baseline
measure: Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.
timeFrame: Baseline
measure: Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.
timeFrame: Baseline
measure: Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.
timeFrame: baseline
measure: Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.
timeFrame: 7 weeks
measure: Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline
timeFrame: baseline
measure: Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks
timeFrame: 7 weeks
measure: Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline
timeFrame: baseline
measure: Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks
timeFrame: 7 weeks
measure: Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline
timeFrame: Baseline
measure: Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks
timeFrame: 7 weeks
measure: Mood Measured by Profile of Mood States at Baseline
timeFrame: baseline
measure: Mood as Measured by Profile of Mood States at 7 Weeks
timeFrame: 7 weeks
measure: Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline
timeFrame: Baseline
measure: Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks
timeFrame: 7 weeks
measure: 1-year Survival
timeFrame: 1 year post study
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Melinda Sheffield-Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott JM, Dillon EL, Kinsky M, Chamberlain A, McCammon S, Jupiter D, Willis M, Hatch S, Richardson G, Danesi C, Randolph K, Durham W, Wright T, Urban R, Sheffield-Moore M. Effects of adjunct testosterone on cardiac morphology and function in advanced cancers: an ancillary analysis of a randomized controlled trial. BMC Cancer. 2019 Aug 7;19(1):778. doi: 10.1186/s12885-019-6006-5.