Clinical trial NCT00378131: Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
Official title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Cachexia
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Sponsor class: INDUSTRY
First posted: 2006-09-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.

Detailed description: Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.
* Involuntary loss of body weight greater than 5% within the past 6 months

Exclusion Criteria:

* Presently hospitalized or in a nursing care facility.
* Inability to increase food intake from secondary causes.
* Liver disease
* If female-pregnant, breast-feeding or of childbearing potential.

Primary outcomes:
measure: Body weight; Lean body mass; Functional performance
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology, Ltd.
state: Arizona
city: Encinitas
country: United States
facility: San Diego Pacific Oncology & Hematology Associates
state: California
city: Santa Monica
country: United States
facility: Sant P. Chawla, MD
state: California
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates
state: Florida
city: Lafayette
country: United States
facility: Southwest Oncology Associates
state: Louisiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Glen Burnie
country: United States
facility: Chesapeake Oncology Hematology Associates, PA
state: Maryland
city: New York
country: United States
facility: Beth Israel Cancer Center
state: New York
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Hilton Head Island
country: United States
facility: South Carolina Cancer Specialists
state: South Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Abingdon
country: United States
facility: Cancer Outreach Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
Study officials:
affiliation: Helsinn Therapeutics (U.S.), Inc
name: William Polvino, MD
role: STUDY_DIRECTOR
References: