Clinical trial · Interventional
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
NCT00878995CI-TRIAL-00032034completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Testosterone | Drug | — | UNRESOLVED |
| Testosterone Enanthate 100 MG/ML | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Standard of Care Therapy + Placebo Testosterone
- description
- Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
- interventionNames
- Drug: Placebo Testosterone
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Therapy + Testosterone
- description
- Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks.
- interventionNames
- Drug: Testosterone Enanthate 100 MG/ML
Primary outcomes (1)
- measure
- Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDScott 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. PMID 31391011