Trial Outcomes & Findings for Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer (NCT NCT00932035)

NCT ID: NCT00932035

Last Updated: 2017-06-07

Results Overview

A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Up to 4 years

Results posted on

2017-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies	Arm II (Control) Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies
Overall Study STARTED	18	21
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) n=18 Participants Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies	Arm II (Control) n=21 Participants Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies	Total n=39 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	47 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	21 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: Because of early termination the study did not accrue the planned number of subjects.

Outcome measures

Outcome measures
Measure	Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) n=11 Participants Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies	Arm II (Control) n=14 Participants Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies
Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein Blue Lymphatic Channels Seen	9 Participants	10 Participants
Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein Blue Lymphatic Channels Not Seen	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: Because of early termination the study did not accrue the planned number of subjects.

A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group.

Outcome measures

Outcome measures
Measure	Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) n=11 Participants Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies	Arm II (Control) n=14 Participants Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies
Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes Blue Lymph Nodes Seen	4 Participants	4 Participants
Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes Blue Lymph Nodes Not Seen	7 Participants	10 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: Because of early termination the study did not accrue the planned number of subjects.

Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.

Outcome measures

Outcome measures
Measure	Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) n=18 Participants Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies	Arm II (Control) n=20 Participants Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies
Percentage of Patients With Lymphedema Lymphedema Present	4 Participants	6 Participants
Percentage of Patients With Lymphedema Lymphedema Not Present	14 Participants	14 Participants

Adverse Events

Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Arm II (Control)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) n=18 participants at risk Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies	Arm II (Control) n=21 participants at risk Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies
Blood and lymphatic system disorders Anemia	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Wound infection	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Additional Information

Carolyn Behrendt, Ph.D.

City of Hope

Phone: (626)359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) n=18 participants at risk Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies	Arm II (Control) n=21 participants at risk Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies
Blood and lymphatic system disorders Anemia	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 3/21 • Number of events 3 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing impaired	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	11.1% 2/18 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	16.7% 3/18 • Number of events 3 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.5% 2/21 • Number of events 4 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Breast infection	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Otitis media	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Wound infection	11.1% 2/18 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	16.7% 3/18 • Number of events 3 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications JP Drain Blood Leak	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Seroma	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Wound dehiscence	11.1% 2/18 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Left Shoulder Joint Stiffness	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 2/18 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain-post op	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	11.1% 2/18 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Breast Swelling	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Breast pain	11.1% 2/18 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/18 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash acneiform	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hematoma	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	5.6% 1/18 • Number of events 1 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/21 • Adverse events were collected over a period of 28 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.