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Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00878995
Recruitment Status : Completed
First Posted : April 9, 2009
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Cachexia
Squamous Cell Carcinoma
Interventions: Drug: Placebo Testosterone
Drug: Testosterone Enanthate 100 MG/ML

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited via UTMB Oncology, Radiation Oncology, and ENT clinics by study physicians.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects began study before beginning chemotherapy and/or radiation therapy. 28 subjects enrolled total. 4 subjects withdrew before beginning the study.

Reporting Groups
  Description
Arm I: Standard of Care Therapy + Placebo Testosterone

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

Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone

Arm II: Standard of Care Therapy + Testosterone

Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.

Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate


Participant Flow for 2 periods

Period 1:   Baseline Study - Midpoint Study
    Arm I: Standard of Care Therapy + Placebo Testosterone   Arm II: Standard of Care Therapy + Testosterone
STARTED   12   12 
Baseline Study   12   12 
COMPLETED   12   10 [1] 
NOT COMPLETED   0   2 
Withdrawal by Subject                0                2 
[1] 2 subjects dropped after the baseline study. They decided to seek treatment closer to home.

Period 2:   Midpoint Study - Post Study
    Arm I: Standard of Care Therapy + Placebo Testosterone   Arm II: Standard of Care Therapy + Testosterone
STARTED   12   10 
COMPLETED   12   10 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I: Standard of Care Therapy + Placebo Testosterone

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

Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone

Arm II: Standard of Care Therapy + Testosterone

Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.

Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate

Total Total of all reporting groups

Baseline Measures
   Arm I: Standard of Care Therapy + Placebo Testosterone   Arm II: Standard of Care Therapy + Testosterone   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (7.97)   48.66  (12.26)   51.44  (10.30) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  41.7%      9  75.0%      14  58.3% 
Male      7  58.3%      3  25.0%      10  41.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2  16.7%      1   8.3%      3  12.5% 
Not Hispanic or Latino      10  83.3%      11  91.7%      21  87.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  16.7%      2  16.7%      4  16.7% 
White      10  83.3%      10  83.3%      20  83.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

1.  Primary:   Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.   [ Time Frame: 7 weeks ]

2.  Secondary:   Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline   [ Time Frame: Baseline ]

3.  Secondary:   Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.   [ Time Frame: 7 weeks ]

4.  Secondary:   Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.   [ Time Frame: Baseline ]

5.  Secondary:   Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks   [ Time Frame: 7 weeks ]

6.  Secondary:   Body Weight as Measured by Scale at Baseline   [ Time Frame: Baseline ]

7.  Secondary:   Body Weight as Measured by Scale at 7 Weeks.   [ Time Frame: 7 weeks ]

8.  Secondary:   Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks   [ Time Frame: 7 weeks ]

10.  Secondary:   Physical Activity Levels as Measured by the ActiGraph Accelerometer   [ Time Frame: through study completion,up to 7 weeks ]

11.  Secondary:   Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline   [ Time Frame: Baseline ]

12.  Secondary:   Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks   [ Time Frame: 7 weeks ]

13.  Secondary:   Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: baseline ]

14.  Secondary:   Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks   [ Time Frame: 7 weeks ]

15.  Secondary:   Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: Baseline ]

16.  Secondary:   Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

17.  Secondary:   Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: baseline ]

18.  Secondary:   Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

19.  Secondary:   Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: baseline ]

20.  Secondary:   Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

21.  Secondary:   Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: Baseline ]

22.  Secondary:   Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

23.  Secondary:   Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: baseline ]

24.  Secondary:   Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

25.  Secondary:   Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: Baseline ]

26.  Secondary:   Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

27.  Secondary:   Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: Baseline ]

28.  Secondary:   Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

29.  Secondary:   Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: baseline ]

30.  Secondary:   Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

31.  Secondary:   Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: Baseline ]

32.  Secondary:   Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

33.  Secondary:   Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: Baseline ]

34.  Secondary:   Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

35.  Secondary:   Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.   [ Time Frame: baseline ]

36.  Secondary:   Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.   [ Time Frame: 7 weeks ]

37.  Secondary:   Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline   [ Time Frame: baseline ]

38.  Secondary:   Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks   [ Time Frame: 7 weeks ]

39.  Secondary:   Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline   [ Time Frame: baseline ]

40.  Secondary:   Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks   [ Time Frame: 7 weeks ]

41.  Secondary:   Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline   [ Time Frame: Baseline ]

42.  Secondary:   Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks   [ Time Frame: 7 weeks ]

43.  Secondary:   Mood Measured by Profile of Mood States at Baseline   [ Time Frame: baseline ]

44.  Secondary:   Mood as Measured by Profile of Mood States at 7 Weeks   [ Time Frame: 7 weeks ]

45.  Secondary:   Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline   [ Time Frame: Baseline ]

46.  Secondary:   Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks   [ Time Frame: 7 weeks ]

47.  Secondary:   1-year Survival   [ Time Frame: 1 year post study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Melinda Sheffield-Moore
Organization: University of Texas Medical Branch
phone: 409-772-8707
e-mail: melmoore@utmb.edu



Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00878995     History of Changes
Other Study ID Numbers: 06-073/10-207
R01CA127971 ( U.S. NIH Grant/Contract )
CDR0000629579
GCRC#724/819
First Submitted: April 8, 2009
First Posted: April 9, 2009
Results First Submitted: September 26, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018