CachexiaPhase 1NCT00878995
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
A Phase 1 study testing Testosterone Enanthate 100 MG/ML in people with Cachexia and Squamous Cell Carcinoma, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cachexia, Squamous Cell Carcinoma
- What is being tested?
- Testosterone Enanthate 100 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2009to Jun 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0361
About this study
Official title: Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
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.
Read the 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.
- Conditions
- Cachexia, Squamous Cell Carcinoma
- Being tested
- Placebo Testosterone, Testosterone Enanthate 100 MG/ML
- Keywords
- stage IIB cervical cancer, stage III cervical cancer, recurrent cervical cancer, cachexia, advanced head/neck carcinoma, recurrent head/neck carcinoma
- Medical subject headings
- Cachexia, Carcinoma, Squamous Cell, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo TestosteroneDrug
Placebo (Saline) Testosterone given IM once per week.
Testosterone Enanthate 100 MG/MLDrug
Testosterone Enanthate 100mg/ml given once per week IM.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Therapy + Placebo Testosterone | Placebo comparator | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Receives: Drug: Placebo Testosterone |
| Standard of Care Therapy + Testosterone | Active comparator | Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks. Receives: Drug: Testosterone Enanthate 100 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.
Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.
Measured: 7 weeks
Secondary outcomes (46)
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.
Measured: Baseline
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.
Measured: 7 weeks
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.
Measured: Baseline
Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.
Measured: 7 weeks
Body Weight as Measured by Scale at Baseline
Body weight in kilograms as measured by a scale at the baseline visit.
Measured: Baseline
Body Weight as Measured by Scale at 7 Weeks.
Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.
Measured: 7 weeks
Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline
Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
Measured: Baseline
Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks
Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
Measured: 7 weeks
Physical Activity Levels as Measured by the ActiGraph Accelerometer
Physical activity is reported as % time sedentary for the entire 7 week study.
Measured: through study completion,up to 7 weeks
Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline
Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: Baseline
Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks
Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: baseline
Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks
Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: Baseline
Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: baseline
Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: baseline
Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: Baseline
Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: baseline
Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: Baseline
Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: Baseline
Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: baseline
Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: Baseline
Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: Baseline
Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.
Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: baseline
Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.
Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Measured: 7 weeks
Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline
Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit
Measured: baseline
Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks
Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.
Measured: 7 weeks
Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline
The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.
Measured: baseline
Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks
The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99
Measured: 7 weeks
Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline
Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.
There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.
The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Measured: Baseline
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks
Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.
There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.
The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Measured: 7 weeks
Mood Measured by Profile of Mood States at Baseline
Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).
Measured: baseline
Mood as Measured by Profile of Mood States at 7 Weeks
Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).
Measured: 7 weeks
Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline
Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).
Measured: Baseline
Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks
Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).
Measured: 7 weeks
1-year Survival
Number of participants who survived one year post study.
Measured: 1 year post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study start3 Jun 2009
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Melinda Sheffield-Moore, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878995
- Sponsor's protocol ID
- 06-073/10-207
- Other IDs
- R01CA127971, CDR0000629579, GCRC#724/819
- Status last verified
- Mar 2018
- First submitted
- 8 Apr 2009
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31391011
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00878995
- Acronym / sponsor ID
- 06-073/10-207
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jun 2009 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Therapy + Placebo Testosterone | Placebo comparator | Drug: Placebo TestosteronePatients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. |
| Standard of Care Therapy + Testosterone | Active comparator | Drug: Testosterone Enanthate 100 MG/MLPatients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo TestosteronePlacebo (Saline) Testosterone given IM once per week. | Drug | Standard of Care Therapy + Placebo Testosterone |
| Testosterone Enanthate 100 MG/MLTestosterone Enanthate 100mg/ml given once per week IM. | Drug | Standard of Care Therapy + Testosterone |
Primary outcome
Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.
Time frame: 7 weeks
Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.
46 secondary outcomes
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline
Time frame: Baseline
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.
Time frame: 7 weeks
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.
Time frame: Baseline
Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks
Time frame: 7 weeks
Body Weight as Measured by Scale at Baseline
Time frame: Baseline
Body Weight as Measured by Scale at 7 Weeks.
Time frame: 7 weeks
Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline
Time frame: Baseline
Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks
Time frame: 7 weeks
Physical Activity Levels as Measured by the ActiGraph Accelerometer
Time frame: through study completion,up to 7 weeks
Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline
Time frame: Baseline
Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks
Time frame: 7 weeks
Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.
Time frame: baseline
Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks
Time frame: 7 weeks
Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.
Time frame: Baseline
Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.
Time frame: baseline
Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.
Time frame: baseline
Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.
Time frame: Baseline
Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.
Time frame: baseline
Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.
Time frame: Baseline
Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.
Time frame: Baseline
Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.
Time frame: baseline
Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.
Time frame: Baseline
Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.
Time frame: Baseline
Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.
Time frame: baseline
Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.
Time frame: 7 weeks
Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline
Time frame: baseline
Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks
Time frame: 7 weeks
Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline
Time frame: baseline
Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks
Time frame: 7 weeks
Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31391011Scott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda Sheffield-Moore, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone Enanthate 100 MG/ML in people with Cachexia and Squamous Cell Carcinoma, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.