Propranolol Dose Escalation in Lymphedema in Patients

NCT02595996 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAP9262
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to investigate the safety and efficacy of propranolol in the treatment of patients with primary lymphedema. The primary goal is to assess patient tolerability of increasing doses of propranolol. The secondary goal is to assess lymphedema symptoms and signs in response to propranolol treatment.

Conditions

Primary Lymphedema

Outcome Measures

Primary Outcomes (1)

• Number of Patients That Tolerated Propranolol

  To assess whether patients tolerated propranolol

  8 weeks

Secondary Outcomes (4)

• Number of Patients With Improved Quality of Life Based on Self-reported Questionnaires

  8 weeks

• Number of Patients With Decreased Fluid Retention by Weight

  8 weeks

• Number of Patients With Lower Limb Discrepancy

  8 weeks

• Number of Patients With Decreased Fluid Retention on MRI

  baseline to 8 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will be given propranolol in escalating doses

Drug: Propranolol

Interventions

Propranolol DRUG

escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day

Also known as: Inderal

Treatment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary lymphedema
• Measurable disease
• Adequate functional status: Karnofsky \>50% (\>age 16), Lanky \>50 (\<age 16),
• No prior therapy within 4 weeks of enrollment
• Adequate bone marrow, renal function, cardiac, and pulmonary function, negative pregnancy test (for women).

You may not qualify if:

• Secondary lymphedema
• Patients already receiving other investigational drugs
• Patients with known contraindications to receiving propranolol
• Other medical comorbidities including but not limited to: pheochromocytoma, bradycardia, bronchospasm/reactive airway disease, decompensated heart failure, heart block, ongoing active infections.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Study terminated due to lack of funding. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Results Point of Contact

• Title: June K. Wu, MD
• Organization: Columbia University Irving Medical Center

jw92@cumc.columbia.edu

212-342-3704

Study Officials

• June K. Wu, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: November 4, 2015
• Study Start: June 7, 2017
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2021

Record last verified: 2021-09

Locations

US (1)