Trial · NCT00031551
Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury
NCT00031551, Phase 2, Terminated, National Institute of Nursing Research (NINR); results first posted 2015-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury. Trials, record NCT00031551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00031551
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury
- NCT number
- NCT00031551
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Conditions
- Stomatitis
- Interventions
- Etanercept, Placebo
- First posted
- 2002-03-08
- Last updated
- 2017-12-06
- Results first posted
- 2015-12-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | What is the Clinical Efficacy of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment-related Stomatitis? | 2 years | Clinical efficacy will be determined by measurement of stomatitis grade and oropharyngeal pain. |
| Secondary | 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? | 2 years | Toxicity will be measured by the incidence of adverse events. |
| Other | Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Day 9 (+/- 24 hours) after conditioning chemotherapy | 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. |
| Other | Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy | day 9 (+/- 24 hours) after conditioning chemotherapy | Participants selected from 14 word descriptors of sensory (S) pain and 11 word descriptors of affective (A) pain. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | What is the Clinical Efficacy of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment-related Stomatitis? | 2 years | Participants withdrew and analyses were terminated before any data collected. | ||
| SECONDARY | 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? | 2 years | event | NUMBER | |
| OTHER_PRE_SPECIFIED | Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Day 9 (+/- 24 hours) after conditioning chemotherapy | One subject was in critical condition at day 9 after CT, preventing data collection at this time | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy | day 9 (+/- 24 hours) after conditioning chemotherapy | One subject was in critical condition at day 9 after CT, preventing data collection at this time | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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? | Main Study Participants | 5 | event | ||
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Baseline Scores | Oral Pain: Overall pain intensity | 0.03 | Standard Deviation 0.16 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Day 9 After CT Scores | Oral Pain: Overall pain intensity | 1.38 | Standard Deviation 2.36 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Baseline Scores | Oral Pain: Pain, Sensory Dimension | 0.12 | Standard Deviation 0.60 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Day 9 After CT Scores | Oral Pain: Pain, Sensory Dimension | 4.75 | Standard Deviation 11.58 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Baseline Scores | Oral Pain: Pain, affective Dimension | 0.04 | Standard Deviation 0.20 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Day 9 After CT Scores | Oral Pain: Pain, affective Dimension | 3.33 | Standard Deviation 9.35 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Baseline Scores | Oral Pain: Pain, Sensory and affective Dimensions | 0.16 | Standard Deviation 0.80 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Day 9 After CT Scores | Oral Pain: Pain, Sensory and affective Dimensions | 8.13 | Standard Deviation 19.79 | units on a scale |
| Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT) | Pilot Study: Baseline Scores | Pain with Swallowing: Overall pain intensity | 0.03 | Standard Deviation 0.16 | units on a scale |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Main Study Participants | 2 | |
| Overall Study | STARTED | Pilot Study | 25 | |
| Overall Study | COMPLETED | Main Study Participants | 0 | |
| Overall Study | COMPLETED | Pilot Study | 25 | |
| Overall Study | NOT COMPLETED | Main Study Participants | 2 | |
| Overall Study | NOT COMPLETED | Pilot Study | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Main Study Participants | 2 | 2 | |
| other | Nausea | Gastrointestinal disorders | Pilot Study | 0 | 0 | |
| other | Fatigue | General disorders | Main Study Participants | 1 | 2 | |
| other | Fatigue | General disorders | Pilot Study | 0 | 0 | |
| other | Diarrhea | Gastrointestinal disorders | Main Study Participants | 2 | 2 | |
| other | Diarrhea | Gastrointestinal disorders | Pilot Study | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Study Participants | ||
| Total, all-cause mortality | Pilot Study | ||
| Total, other adverse events | Main Study Participants | 2 | 2 |
| Total, other adverse events | Pilot Study | 0 | 0 |
| Total, serious adverse events | Main Study Participants | 0 | 2 |
| Total, serious adverse events | Pilot Study | 0 | 0 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00031551
GET https://conductscience.org/api/trials/v1/NCT00031551/results?page=2