Phase 1
N=24
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Cachexia · Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00878995 ↗Enrolled (actual)
24
Serious AEs
50.0%
Results posted
Mar 2018
Primary outcome: Primary: Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. — -3.31; 1.42 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo Testosterone (Drug); Testosterone Enanthate 100 MG/ML (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. |
-3.31; 1.42 | — |
| SECONDARY Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline |
81.77; 122.50 | — |
| SECONDARY Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks. |
76.75; 118.26 | — |
| SECONDARY Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline. |
137.60; 169.0 | — |
| SECONDARY Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks |
126.93; 157.90 | — |
| SECONDARY Body Weight as Measured by Scale at Baseline |
65.98; 63.11 | — |
| SECONDARY Body Weight as Measured by Scale at 7 Weeks. |
63.93; 62.59 | — |
| SECONDARY Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline |
1329.20; 1310.81 | — |
| SECONDARY Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks |
1338.10; 1260.98 | — |
| SECONDARY Physical Activity Levels as Measured by the ActiGraph Accelerometer |
73.55; 74.74 | — |
| SECONDARY Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline |
67.02; 260.69 | — |
| SECONDARY Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks |
64.15; 191.17 | — |
| SECONDARY Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline. |
21.62; 15.71 | — |
| SECONDARY Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks |
20.63; 11.66 | — |
| SECONDARY Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline. |
3.11; 1.98 | — |
| SECONDARY Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks. |
2.13; 1.71 | — |
| SECONDARY Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline. |
3.62; 3.92 | — |
| SECONDARY Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks. |
3.02; 2.39 | — |
| SECONDARY Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline. |
4.30; 3.13 | — |
| SECONDARY Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks. |
10.48; 2.35 | — |
| SECONDARY Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline. |
3.02; 14.56 | — |
| SECONDARY Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks. |
3.13; 12.62 | — |
| SECONDARY Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline. |
11.04; 43.99 | — |
| SECONDARY Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks. |
8.89; 23.09 | — |
| SECONDARY Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline. |
6.57; 21.61 | — |
| SECONDARY Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks. |
9.97; 18.16 | — |
| SECONDARY Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline. |
14.57; 16.62 | — |
| SECONDARY Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks. |
11.45; 12.34 | — |
| SECONDARY Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline. |
13.35; 94.52 | — |
| SECONDARY Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks. |
12.84; 82.46 | — |
| SECONDARY Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline. |
3.94; 44.04 | — |
| SECONDARY Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks. |
4.36; 28.36 | — |
| SECONDARY Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline. |
2.50; 20.50 | — |
| SECONDARY Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks. |
3.82; 17.95 | — |
| SECONDARY Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline. |
11.87; 13.88 | — |
| SECONDARY Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks. |
33.52; 12.22 | — |
| SECONDARY Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline |
20513.50; 18227.33 | — |
| SECONDARY Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks |
17616.58; 16776.60 | — |
| SECONDARY Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline |
47.73; 52.22 | — |
| SECONDARY Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks |
52.73; 46.50 | — |
| SECONDARY Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline |
12.73; 21.40 | — |
| SECONDARY Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks |
18.73; 26.11 | — |
| SECONDARY Mood Measured by Profile of Mood States at Baseline |
30.73; 32.55 | — |
| SECONDARY Mood as Measured by Profile of Mood States at 7 Weeks |
28.82; 35.78 | — |
| SECONDARY Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline |
18.83; 30.48 | — |
| SECONDARY Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks |
20.11; 24.97 | — |
| SECONDARY 1-year Survival |
7; 6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00878995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.