Trial Outcomes & Findings for Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury (NCT NCT00031551)
NCT ID: NCT00031551
Last Updated: 2017-12-06
Results Overview
Clinical efficacy will be determined by measurement of stomatitis grade and oropharyngeal pain.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
2 years
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
Main Study Participants
Participants were randomized to one of the following two interventions but the study was not unblinded.
1. Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
2. Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
|
Pilot Study
Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
25
|
|
Overall Study
COMPLETED
|
0
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Main Study Participants
Participants were randomized to one of the following two interventions but the study was not unblinded.
1. Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
2. Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
|
Pilot Study
Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
|
|---|---|---|
|
Overall Study
Withdrew due to chemotherapy effects
|
2
|
0
|
Baseline Characteristics
Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury
Baseline characteristics by cohort
| Measure |
Main Study Participants
n=2 Participants
Participants were randomized to one of the following two interventions but the study was not unblinded.
1. Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
2. Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
|
Pilot Study
n=25 Participants
Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
46 years
n=7 Participants
|
NA years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
25 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Education
Grade School
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Education
High School
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Education
Some College
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Education
College Graduate
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Education
Graduate School
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Cancer Diagnosis
Breast Cancer
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Cancer Diagnosis
Non-Hodgkin's Lymphoma
|
1 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Cancer Diagnosis
Hodgkin's Lymphoma
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Cancer Diagnosis
Multiple Myeloma
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Cancer Diagnosis
Leukemia
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Cancer stage
Stage II
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cancer stage
Stage III
|
1 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Cancer stage
Stage IV
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Cancer stage
Unstaged
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cancer stage
First Remission
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cancer stage
Second Remission
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cancer stage
Accelerated Phase
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cancer stage
Unknown
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants withdrew and analyses were terminated before any data collected.
Clinical efficacy will be determined by measurement of stomatitis grade and oropharyngeal pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsToxicity will be measured by the incidence of adverse events.
Outcome measures
| Measure |
Main Study: Etanercept Mouthwash
n=2 Participants
Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Etanercept
|
Main Study: Placebo Mouthwash
Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
Placebo
|
|---|---|---|
|
What is the Toxicity of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment -Related Stomatitis?
|
5 event
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 9 (+/- 24 hours) after conditioning chemotherapyPopulation: One subject was in critical condition at day 9 after CT, preventing data collection at this time
Subjects rated pain using the Painometer, a hand-held tool with a visual analogue scale to rate overall pain intensity and a list of 14 sensory and 11 affective pain descriptors ranked by intensity values from 1 - 5. Subjects look at the list of sensory and affective words and select words that describe their pain, including Oral Pain and Oral Pain with Swallowing. . The weighted scores assigned to the words are added to obtain a pain intensity score for the sensory and the affective components. The overall pain intensity is measured on a visual analogue scale which has a range of 1 - 10 with high scores indicating higher pain intensity. The sensory and affective pain scores are otained by adding all of the respective intensity values. The range of possible sensory scores is from 0 - 48 and the range of possible affective scores is from 0 - 37. The sensory and affective scores may be added together to obtain the total pain intensity score, which may range from 0 - 85.
Outcome measures
| Measure |
Main Study: Etanercept Mouthwash
n=24 Participants
Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Etanercept
|
Main Study: Placebo Mouthwash
n=24 Participants
Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
Placebo
|
|---|---|---|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Oral Pain: Pain, Sensory Dimension
|
0.12 units on a scale
Standard Deviation 0.60
|
4.75 units on a scale
Standard Deviation 11.58
|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Oral Pain: Pain, affective Dimension
|
0.04 units on a scale
Standard Deviation 0.20
|
3.33 units on a scale
Standard Deviation 9.35
|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Oral Pain: Pain, Sensory and affective Dimensions
|
0.16 units on a scale
Standard Deviation 0.80
|
8.13 units on a scale
Standard Deviation 19.79
|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Pain with Swallowing: Overall pain intensity
|
0.03 units on a scale
Standard Deviation 0.16
|
2.28 units on a scale
Standard Deviation 3.38
|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Pain with Swallowing: Pain, Sensory Dimension
|
0.08 units on a scale
Standard Deviation 0.40
|
5.48 units on a scale
Standard Deviation 11.69
|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Pain with Swallowing: Pain, Affective Dimension
|
0 units on a scale
Standard Deviation 0
|
4.09 units on a scale
Standard Deviation 10.25
|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Pain with Swallowing:Sensory & Affective Dimension
|
0.08 units on a scale
Standard Deviation 0.40
|
9.61 units on a scale
Standard Deviation 21.71
|
|
Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)
Oral Pain: Overall pain intensity
|
0.03 units on a scale
Standard Deviation 0.16
|
1.38 units on a scale
Standard Deviation 2.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 9 (+/- 24 hours) after conditioning chemotherapyPopulation: One subject was in critical condition at day 9 after CT, preventing data collection at this time
Participants selected from 14 word descriptors of sensory (S) pain and 11 word descriptors of affective (A) pain.
Outcome measures
| Measure |
Main Study: Etanercept Mouthwash
n=24 Participants
Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Etanercept
|
Main Study: Placebo Mouthwash
Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
Placebo
|
|---|---|---|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Cramping, radiation, sharp
|
4.2 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory: Splitting, shooting, stabbing, tearing
|
8.3 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Dull, burning, crushing, pressing
|
12.5 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Aching
|
16.7 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Hurting
|
20.8 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Sore
|
29.2 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: torturing, splitting, crushing
|
4.2 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
S:Cramping, shooting, radiating, stabbing, tearing
|
8.3 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Dull, aching, pressing
|
12.5 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Hurting Group 2
|
16.7 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Burning, sharp
|
20.8 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Sensory words: Sore Group 2
|
29.2 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Affective words: Terrifying, torturing
|
4.2 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Affective: Killing, tiring, unbearable, sickening
|
8.3 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
A: Nagging, agonizing, troublesome, miserable
|
12.5 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Affective words: Annoying
|
25.0 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Affective words: Torturing
|
4.2 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Affective words: Killing, unbearable, terrifying
|
8.3 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
A: Agonizing, troublesome, tiring, sickening
|
12.5 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Affective words: Miserable, nagging
|
16.7 percentage of participants
|
—
|
|
Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy
Affective words: Annoying Group 2
|
20.8 percentage of participants
|
—
|
Adverse Events
Main Study Participants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Main Study Participants
n=2 participants at risk
Participants were randomized to one of the following two interventions but the study was not unblinded.
1. Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
2. Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
|
Pilot Study
Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2
Adverse events were not assessed for the pilot study.
|
—
0/0
Adverse events were not assessed for the pilot study.
|
|
General disorders
Fatigue
|
50.0%
1/2
Adverse events were not assessed for the pilot study.
|
—
0/0
Adverse events were not assessed for the pilot study.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2
Adverse events were not assessed for the pilot study.
|
—
0/0
Adverse events were not assessed for the pilot study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place