Trial Outcomes & Findings for Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy (NCT NCT01611155)

Last Updated: 2019-09-26

Results Overview

The EORTC QLQ-CIPN20 sensory neuropathy score will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Up to 2 weeks

Results posted on

2019-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Venlafaxine) Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Arm II (Placebo) Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Overall Study STARTED	25	25
Overall Study Received Treatment	25	25
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Venlafaxine) Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Arm II (Placebo) Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Overall Study Adverse Event	1	1
Overall Study Refused further treatment	6	4
Overall Study Disease progression	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Alternative treatment	0	1
Overall Study Ineligible patient	0	1

Baseline Characteristics

Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Venlafaxine) n=24 Participants Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Arm II (Placebo) n=24 Participants Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Total n=48 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 11.3 • n=5 Participants	58.4 years STANDARD_DEVIATION 10.3 • n=7 Participants	60.3 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks

Population: Patients who completed the (QLQ)-CIPN20 Sensory neuropathy items at cycle 1 are included in this analysis.

Outcome measures

Outcome measures
Measure	Arm I (Venlafaxine) n=21 Participants Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Arm II (Placebo) n=20 Participants Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20	96.22 score on a scale Standard Deviation 5.88	95.83 score on a scale Standard Deviation 8.84

SECONDARY outcome

Timeframe: Up to 2 weeks

Population: There were a few Venlafaxine patients who completed the items for the motor subscale but did not complete the items for autonomic subscale in cycle 1 and thus the number analyzed for each subscale is different on the venlafaxine arm.

The EORTC QLQ-CIPN20 motor and autonomic neuropathy scores will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation.

Outcome measures

Outcome measures
Measure	Arm I (Venlafaxine) n=20 Participants Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Arm II (Placebo) n=21 Participants Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Cycle 1 Acute Neuropathy as Measured by EORTC QLQ CIPN20 Motor Subscale (Items 37, 38, 41-45 and 49), and Autonomic Scale (Items 46, 47, 50) Motor subscale	97.28 score on a scale Standard Deviation 6.33	95.98 score on a scale Standard Deviation 6.82
Cycle 1 Acute Neuropathy as Measured by EORTC QLQ CIPN20 Motor Subscale (Items 37, 38, 41-45 and 49), and Autonomic Scale (Items 46, 47, 50) Autonomic subscale	91.36 score on a scale Standard Deviation 15.03	90.74 score on a scale Standard Deviation 12.34

Adverse Events

Arm I (Venlafaxine)

Serious events: 2 serious events

Other events: 21 other events

Deaths: 1 deaths

Arm II (Placebo)

Serious events: 2 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Venlafaxine) n=24 participants at risk Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Arm II (Placebo) n=25 participants at risk Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Gastrointestinal disorders Colonic obstruction	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Gastrointestinal disorders Diarrhea	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
General disorders Edema limbs	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Infections and infestations Catheter related infection	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Vascular disorders Hematoma	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Vascular disorders Thromboembolic event	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.

Other adverse events

Additional Information

Charles L. Loprinzi, MD

Mayo Clinic

Phone: 507-284-3731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Venlafaxine) n=24 participants at risk Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.	Arm II (Placebo) n=25 participants at risk Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Blood and lymphatic system disorders Anemia	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	8.0% 2/25 • Number of events 2 All patients who received treatment and submitted an AE form are included in the summary below.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	8.0% 2/25 • Number of events 2 All patients who received treatment and submitted an AE form are included in the summary below.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Gastrointestinal disorders Mucositis oral	8.3% 2/24 • Number of events 2 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Gastrointestinal disorders Nausea	62.5% 15/24 • Number of events 52 All patients who received treatment and submitted an AE form are included in the summary below.	56.0% 14/25 • Number of events 47 All patients who received treatment and submitted an AE form are included in the summary below.
Gastrointestinal disorders Vomiting	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
General disorders Fatigue	4.2% 1/24 • Number of events 3 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.
Immune system disorders Allergic reaction	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Immune system disorders Anaphylaxis	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.
Infections and infestations Infections and infestations - Other, specify	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.
Investigations Blood bilirubin increased	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.
Investigations Neutrophil count decreased	25.0% 6/24 • Number of events 19 All patients who received treatment and submitted an AE form are included in the summary below.	16.0% 4/25 • Number of events 7 All patients who received treatment and submitted an AE form are included in the summary below.
Investigations Platelet count decreased	4.2% 1/24 • Number of events 7 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.
Investigations Weight loss	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.
Metabolism and nutrition disorders Anorexia	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 5 All patients who received treatment and submitted an AE form are included in the summary below.
Nervous system disorders Headache	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 2 All patients who received treatment and submitted an AE form are included in the summary below.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 2 All patients who received treatment and submitted an AE form are included in the summary below.
Nervous system disorders Peripheral sensory neuropathy	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	8.0% 2/25 • Number of events 3 All patients who received treatment and submitted an AE form are included in the summary below.
Nervous system disorders Somnolence	16.7% 4/24 • Number of events 4 All patients who received treatment and submitted an AE form are included in the summary below.	8.0% 2/25 • Number of events 17 All patients who received treatment and submitted an AE form are included in the summary below.
Psychiatric disorders Agitation	8.3% 2/24 • Number of events 2 All patients who received treatment and submitted an AE form are included in the summary below.	8.0% 2/25 • Number of events 2 All patients who received treatment and submitted an AE form are included in the summary below.
Psychiatric disorders Anxiety	20.8% 5/24 • Number of events 19 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Vascular disorders Hypertension	29.2% 7/24 • Number of events 34 All patients who received treatment and submitted an AE form are included in the summary below.	40.0% 10/25 • Number of events 57 All patients who received treatment and submitted an AE form are included in the summary below.
Vascular disorders Superficial thrombophlebitis	0.00% 0/24 All patients who received treatment and submitted an AE form are included in the summary below.	4.0% 1/25 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.
Vascular disorders Thromboembolic event	4.2% 1/24 • Number of events 1 All patients who received treatment and submitted an AE form are included in the summary below.	0.00% 0/25 All patients who received treatment and submitted an AE form are included in the summary below.