A Pilot Study To Evaluate Patient Experience With the Somatostatin Analogs Octreotide Long Acting Release and Lanreotide During the Treatment of Advanced, Nonfunctional, Well Differentiated Neuroendocrine Tumors
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 51
- Locations
- 7
- Primary Endpoint
- Mean Pain Scores at 3 Months
Study Overview
Brief Summary
This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing and able to provide written informed consent for the trial
- •≥ 18 years of age
- •Histologically- or cytologically- confirmed locally advanced or metastatic WDNET
- •SSA therapy is recommended by physician for disease management, and has not yet begun
- •ECOG performance status of 0, 1, or 2
Exclusion Criteria
- •Currently participating in a study of an investigational agent
- •Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
- •*Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study
- •No concurrent chemotherapy or targeted small molecule therapy
- •If received major surgery, not recovered adequately from the toxicity and/or complications from the intervention prior to starting the study
- •Known additional malignancy that is progressing or requires active treatment
- •Active infection requiring systemic therapy
- •Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Arms & Interventions
Octreotide then Lanreotide
Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Intervention: Octreotide (Drug)
Octreotide then Lanreotide
Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Intervention: LAR Lanreotide (Drug)
Octreotide then Lanreotide
Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Intervention: Questionnaires (Behavioral)
Lanreotide then Octreotide
Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Intervention: Octreotide (Drug)
Lanreotide then Octreotide
Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Intervention: LAR Lanreotide (Drug)
Lanreotide then Octreotide
Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Intervention: Questionnaires (Behavioral)
Outcomes
Primary Outcomes
Mean Pain Scores at 3 Months
Time Frame: 3 months
Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.
Secondary Outcomes
No secondary outcomes reported