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| ID | Type | Description | Link |
|---|---|---|---|
| P-07-020 | Other Grant/Funding Number | Cancer Treatment Research Foundation (CTRF) | |
| NCI-2011-03238 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Spring Wind Herbs | UNKNOWN |
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The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).
The purpose of this study is to test a new noninvasive topical cream, AIJP (Arnebia Indigo Jade Pearl), for treatment of precancerous anal lesions in order to prevent their progression to anal cancer. AIJP is a topical Chinese herbal cream that has been specifically designed to treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In general, HPV infection is a key factor in development of cervical, anal and vulvar cancers. People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is known that prior to development of anal cancer a person develops a precancerous condition known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high impact on prevention of anal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIJP (Arnebia Indigo Jade Pearl) | Drug | Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) | Response assessed 12 weeks after treatment. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences) Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved) No Response (NR): HSIL present at weeks 48 & 60 on histology, or improvement ≤ 50% in number, size, area or characteristics. | Baseline, Week 48, and Week 60; up to 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Adherence | Percent of recommended applications of cream reported in participant diary. >75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent | Up to 48 weeks |
| Response With >50% Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Misha R Cohen, OMD, LAc | Chicken Soup Chinese Medicine | Principal Investigator |
| Naomi Jay, PhD, FNP | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AIJP | AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks. |
| FG001 | Placebo | Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline - Week 12 (Treatment) |
|
| ||||||||||||||||||
| Week 12 - Week 48 (Treatment) |
| |||||||||||||||||||
| Week 60 (Post-treatment Follow-up Visit) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AIJP | AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks. |
| BG001 | Placebo | Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) | Response assessed 12 weeks after treatment. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences) Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved) No Response (NR): HSIL present at weeks 48 & 60 on histology, or improvement ≤ 50% in number, size, area or characteristics. | Posted | Number | participants | Baseline, Week 48, and Week 60; up to 60 weeks |
|
60 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIJP | AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perianal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Superficially invasive cancer possibly present at baseline; participant non-evaluable for study outcomes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naomi Jay, PhD | University of California, San Francisco | 415-353-7443 | Naomi.Jay@ucsf.edu |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| Placebo | Drug | Placebo twice daily for 48 weeks. |
|
Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.
Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60.
Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)
Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in number of lesions with HSIL, or improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)
No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics.
| Baseline, Week 48, and Week 60; up to 60 weeks |
| Response With >75% Adherence | Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences) Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved) No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics. | Baseline, Week 48, and Week 60; up to 60 weeks |
| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| AIJP |
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks. |
| OG001 | Placebo | Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks. |
|
|
|
| Secondary | Treatment Adherence | Percent of recommended applications of cream reported in participant diary. >75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent | Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable. | Posted | Number | participants | Up to 48 weeks |
|
|
|
| Secondary | Response With >50% Adherence | Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences) Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in number of lesions with HSIL, or improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved) No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics. | Evaluable participants who finished 48 weeks of treatment and reported >50% adherence to treatment | Posted | Number | participants | Baseline, Week 48, and Week 60; up to 60 weeks |
|
|
|
| Secondary | Response With >75% Adherence | Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences) Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved) No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics. | Evaluable participants who finished 48 weeks of treatement and reported >75% adherence to treatment | Posted | Number | participants | Baseline, Week 48, and Week 60; up to 60 weeks |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo | Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks. | 0 | 35 | 1 | 35 | 0 | 35 |
|
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| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| Poor |
|
| Non-adherent |
|
| PCR |
|
| NR |
|
| PCR |
|
| NR |
|