Trial Outcomes & Findings for Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab (NCT NCT01393821)

Last Updated: 2025-05-16

Results Overview

Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

From Baseline to Week 4

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Menadione) Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) Patients apply topical placebo lotion BID for 28 days.
Overall Study STARTED	14	13
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Menadione) Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) Patients apply topical placebo lotion BID for 28 days.
Overall Study Cancel	1	1
Overall Study not evaluable for primary endpoint	4	2

Baseline Characteristics

Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Menadione) n=13 Participants Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) n=12 Participants Patients apply topical placebo lotion BID for 28 days.	Total n=25 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 9.3 • n=5 Participants	64.3 years STANDARD_DEVIATION 12.6 • n=7 Participants	63.4 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 4

Population: Patients who completed the face pain question at baseline and week 4 are included in this analysis.

Outcome measures

Outcome measures
Measure	Arm A (Menadione) n=8 Participants Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) n=10 Participants Patients apply topical placebo lotion BID for 28 days.
Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort	2.0 score on a scale Interval 0.0 to 4.0	3.0 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Excludes cancel patients who never received treatment.

The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm.

Outcome measures

Outcome measures
Measure	Arm A (Menadione) n=13 Participants Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) n=12 Participants Patients apply topical placebo lotion BID for 28 days.
The Number of Patients Experiencing Worst Toxicity Grade 1	3 Participants	3 Participants
The Number of Patients Experiencing Worst Toxicity Grade 2	7 Participants	6 Participants
The Number of Patients Experiencing Worst Toxicity Grade 3	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: Excludes cancel patients who never received treatment.

Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (\<=50 years/\>50 years), and EGFR, via a MMRM analysis. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.

Outcome measures

Outcome measures
Measure	Arm A (Menadione) n=13 Participants Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) n=12 Participants Patients apply topical placebo lotion BID for 28 days.
Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)	2.1820 score on a scale Standard Error 0.5003	1.8244 score on a scale Standard Error 0.4376

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Excludes cancel patients who never received treatment.

Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (\<=50 years/\>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered.

Outcome measures

Outcome measures
Measure	Arm A (Menadione) n=13 Participants Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) n=12 Participants Patients apply topical placebo lotion BID for 28 days.
Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)	0.7196 score on a scale Standard Error 0.3436	1.1891 score on a scale Standard Error 0.3043

Adverse Events

Arm A (Menadione)

Serious events: 2 serious events

Other events: 11 other events

Deaths: 2 deaths

Arm B (Placebo)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (Menadione) n=12 participants at risk Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) n=13 participants at risk Patients apply topical placebo lotion BID for 28 days.
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	0.00% 0/13 • Up to 8 weeks Excludes cancel patients who never received treatment.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	0.00% 0/13 • Up to 8 weeks Excludes cancel patients who never received treatment.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	0.00% 0/13 • Up to 8 weeks Excludes cancel patients who never received treatment.
Nervous system disorders Stroke	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	0.00% 0/13 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/12 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.

Other adverse events

Other adverse events
Measure	Arm A (Menadione) n=12 participants at risk Patients apply menadione topical lotion BID for 28 days.	Arm B (Placebo) n=13 participants at risk Patients apply topical placebo lotion BID for 28 days.
Ear and labyrinth disorders Ear pain	0.00% 0/12 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
Gastrointestinal disorders Mucositis oral	8.3% 1/12 • Number of events 2 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
General disorders Facial pain	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	0.00% 0/13 • Up to 8 weeks Excludes cancel patients who never received treatment.
General disorders Fatigue	0.00% 0/12 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
General disorders Pain	0.00% 0/12 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
Metabolism and nutrition disorders Dehydration	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/12 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	7.7% 1/13 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/12 • Up to 8 weeks Excludes cancel patients who never received treatment.	23.1% 3/13 • Number of events 3 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Pruritus	41.7% 5/12 • Number of events 6 • Up to 8 weeks Excludes cancel patients who never received treatment.	69.2% 9/13 • Number of events 11 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	83.3% 10/12 • Number of events 16 • Up to 8 weeks Excludes cancel patients who never received treatment.	92.3% 12/13 • Number of events 16 • Up to 8 weeks Excludes cancel patients who never received treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	8.3% 1/12 • Number of events 1 • Up to 8 weeks Excludes cancel patients who never received treatment.	0.00% 0/13 • Up to 8 weeks Excludes cancel patients who never received treatment.

Additional Information

Aminah Jatoi, M.D.

Mayo Clinic

Phone: (507) 284-7202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place