Clinical trial · Interventional
Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx
Pilot Study of Phosphodiesterase-5 Inhibitor Tadalafil (Cialis) as an Immunomodulator in Patients With Oral Cavity and Oropharyngeal Squamous Cell Carcinoma.
NCT00843635CI-TRIAL-00019505completedN/AResults 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: Biological therapies, such as tadalafil, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This randomized clinical trial is studying how well tadalafil works in treating patients who are undergoing surgery for cancer of the oral cavity or oropharynx.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Tadalafil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A - Tadalafil 10mg
- description
- Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
- interventionNames
- Drug: Tadalafil
- type
- EXPERIMENTAL
- label
- Arm B - Tadalafil 20mg
- description
- Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
- interventionNames
- Drug: Tadalafil
- type
- PLACEBO_COMPARATOR
- label
- Arm C - Placebo
- description
- Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Patients with surgically resectable oral cavity SCC, all subsites, T1 - T4, N0 - N3 * Patients with surgically resectable oropharyngeal SCC, all subsites, T1 - T2, N0 - N1 * Patients with surgically resectable T4 oropharyngeal SCC, all subsites, N0 - N3 * Patients must be 18 years old or older EXCLUSION CRITERIA: * Patients with previous surgical resection, radiation, or chemotherapy will be excluded to rule out possible effects of local tissue changes secondary to previous treatment * Patients with surgically unresectable disease at primary site or regional lymph nodes * Patients with T1 - T2 SCC oropharynx, N2 - N3 * Patients with T3 SCC oropharynx , N0 - N3 * Any patient for whom non-surgical therapy is recommended as treatment of choice after multidisciplinary treatment evaluation * Patients with an altered mental status or not capacitated for their medical decision making * Patients with severe or unstable cardiac or cerebrovascular disease are excluded * myocardial infarction within the last 90 days * unstable angina or angina occurring during sexual intercourse * New York Heart Association Class 2 or greater heart failure in the last 6 months * uncontrolled arrhythmias * hypotension (\<90/50 mm Hg), or uncontrolled hypertension (\>170/100 mm Hg) * stroke within the last 6 months * Left ventricle outflow obstruction. * Pregnant and nursing mothers will not be enrolled given unknown effects to offspring * Concurrent nitrate, alpha-blocker, or cytochrome P-450 inhibitor use * Renal Insufficiency defined as creatinine clearance less than 51. * Creatinine clearance will be determined by the following Cockcroft-Gault Equation: (140-age) \* (Wt in kg) \* (0.85 if female) / (72 \* Cr) * Patients with hepatic insufficiency. * Patients currently taking a Phosphodiesterase (PDE) inhibitors for erectile dysfunction * Patients who are immunocompromised, for reasons not directly related to patients malignancy * Patients with significant alcohol or drug abuse * Patients with unilateral blindness, hereditary retinal disorders, or increased risk of blindness * Patients with unilateral deafness, history of hearing loss, hearing aid dependence, or clinically evident hearing loss
References
Publications (1)
- RESULTWeed DT, Vella JL, Reis IM, De la Fuente AC, Gomez C, Sargi Z, Nazarian R, Califano J, Borrello I, Serafini P. Tadalafil reduces myeloid-derived suppressor cells and regulatory T cells and promotes tumor immunity in patients with head and neck squamous cell carcinoma. Clin Cancer Res. 2015 Jan 1;21(1):39-48. doi: 10.1158/1078-0432.CCR-14-1711. Epub 2014 Oct 15. PMID 25320361