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| Name | Class |
|---|---|
| American Institute for Cancer Research | OTHER |
| Breast Cancer Research Foundation | OTHER |
| Hopkins-WellSpan Cancer Research Fund | UNKNOWN |
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This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.
The investigators will evaluate the extent to which implementation of a chronic weight loss medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss. All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. During month 3, all participants continue to have weekly calls with the behavioral coach and will be asked about symptoms, which may be related to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation. In addition to total weight loss, the investigators will evaluate biomarkers associated with obesity, microbiome and cardiometabolic factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLOW-BWL | Experimental | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. |
|
| FAST-BWL | Active Comparator | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrave | Drug | Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With 5 Percent Weight Loss (in SLOW-BWL) | To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. The total score ranges from 33.5 to 61.7. The higher the score, the better the physical function. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With 5% Weight Loss (in FAST-BWL) | To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Serious/uncontrolled medical condition at the discretion of the Protocol Chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery)
Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication.
Diabetes on insulin or sulfonylureas within the past 3 months
Unstable psychiatric disorder or bulimia/anorexia nervosa
Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol, benzodiazepine, barbiturate or anti-epileptic drug
Use of the following medications are excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Sheng | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SLOW-BWL | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. Contrave: Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6. Behavioral Weight Loss: 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. |
| FG001 | FAST-BWL | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) Behavioral Weight Loss: 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SLOW-BWL | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. Contrave: Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6. Behavioral Weight Loss: 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Patients With 5 Percent Weight Loss (in SLOW-BWL) | To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9. | Only 32 participants in the SLOW-BWL arm completed intervention per protocol | Posted | Count of Participants | Participants | 6 months |
|
Initiation of drug up to 6 months
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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 | SLOW-BWL | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. Contrave: Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6. Behavioral Weight Loss: 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Sheng | SKCCC | 410-614-0762 | jsheng7@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2024 | Jan 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
| D009271 | Naltrexone |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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|
| Behavioral Weight Loss | Behavioral | 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. |
|
| Baseline, 2 months and 6 Months |
| Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. The total score ranges from 41.0-67.4. The lower the score, the better the pain interference. | Baseline, 2 months and 6 Months |
| Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. The total score ranges from 39.6 to 62.0. The lower the score, the less the fatigue. | Baseline, 2 months and 6 Months |
| Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Depression. The total score ranges from 37.1-71.4. The lower the score, the less depression. | Baseline, 2 months and 6 Months |
| Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety. Scores range 36.3-71.5, with higher scores representing more severe anxiety symptoms. | Baseline, 2 months and 6 Months |
| Change in Scores on the Medical Outcomes Study (MOS) Sexual Functioning Scale Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Medical Outcomes Study (MOS) Sexual Function. Score range 0-100 with higher score indicating less functioning. Four items are rated on a 5-point scale (1=not a problem, 2=little of a problem, 3=somewhat of a problem, 4=very much of a problem, and 5=not applicable). | Baseline, 2 months and 6 Months |
| Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES). Scores ranging from 39.0 to 73.0. Higher scores indicate greater impact from symptoms. | Baseline, 2 months and 6 Months |
| BG001 | FAST-BWL | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) Behavioral Weight Loss: 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Breast Cancer Stage | Breast cancer stage at study entry: Ductal carcinoma in situ (DCIS), Stage 1, Stage 2 or Stage 3. Staging done with The American Joint Committee on Cancer (AJCCC) Version 8. Higher stage is worse. | Count of Participants | Participants |
|
|
|
| Secondary | Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. The total score ranges from 33.5 to 61.7. The higher the score, the better the physical function. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months and 6 Months |
|
|
|
| Secondary | Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. The total score ranges from 41.0-67.4. The lower the score, the better the pain interference. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months and 6 Months |
|
|
|
| Secondary | Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. The total score ranges from 39.6 to 62.0. The lower the score, the less the fatigue. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months and 6 Months |
|
|
|
| Secondary | Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Depression. The total score ranges from 37.1-71.4. The lower the score, the less depression. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months and 6 Months |
|
|
|
| Secondary | Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety. Scores range 36.3-71.5, with higher scores representing more severe anxiety symptoms. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months and 6 Months |
|
|
|
| Secondary | Change in Scores on the Medical Outcomes Study (MOS) Sexual Functioning Scale Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Medical Outcomes Study (MOS) Sexual Function. Score range 0-100 with higher score indicating less functioning. Four items are rated on a 5-point scale (1=not a problem, 2=little of a problem, 3=somewhat of a problem, 4=very much of a problem, and 5=not applicable). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months and 6 Months |
|
|
|
| Secondary | Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES). Scores ranging from 39.0 to 73.0. Higher scores indicate greater impact from symptoms. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months and 6 Months |
|
|
|
| Other Pre-specified | Number of Patients With 5% Weight Loss (in FAST-BWL) | To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 28 |
| 38 |
| EG001 | FAST-BWL | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) Behavioral Weight Loss: 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. | 0 | 15 | 0 | 15 | 4 | 15 |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |