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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05455 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| 10559 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Safeway Foundation | UNKNOWN |
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This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.
ARM II: Patients undergo standard of care oral cryotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (acupuncture, acupressure, cryotherapy) | Experimental | Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. |
|
| Arm II (cryotherapy) | Active Comparator | Patients undergo standard of care oral cryotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture Therapy | Procedure | Undergo acupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months | Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy | Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate. | 3 months |
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Inclusion Criteria:
GI cancer (primary esophagus, gastric, pancreas, biliary, liver, small bowel, appendix, colon, rectal, anal, or gastrointestinal/pancreatic neuroendocrine tumor) scheduled to receive a new start of fluorouracil (5-FU), oxaliplatin, +/- irinotecan (fluorouracil/leucovorin calcium/oxaliplatin [FOLFOX], fluorouracil/irinotecan/leucovorin calcium/oxaliplatin [FOLFIRINOX], leucovorin/fluorouracil/oxaliplatin/irinotecan [FOLFOXIRI] regimens) with plan for >= 3 months of therapy with the regimen. Chemotherapy can be given for neoadjuvant, adjuvant, or palliative intent. 1 dose (cycle) of the intended regimen is permitted prior to study enrollment.
**There is no limitation on the addition of a biologic agent to one of the above chemotherapy regimens, including, but not limited to: bevacizumab, cetuximab, panitumumab, trastuzumab, or the biosimilars of these agents
Age >=18 years
Absolute neutrophil count > 0.5 thousand/microL
Platelet count > 20 thousand/microL
Not currently pregnant
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey Cohen | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Acupuncture, Acupressure, Cryotherapy) | Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 27, 2023 |
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| Acupressure Therapy | Procedure | Undergo acupressure |
|
|
| Oral Cryotherapy | Procedure | Undergo oral cryotherapy |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure | The Neuropen is used to assess pressure perception. Pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot at each of the ten different sites recorded as present or absent. The proportion present was calculated for each patient at baseline and at 3 months. The difference between these proportions from baseline to 3 months was calculated for each patient. The mean of these differences was calculated within each arm and the difference of those means was then compared between arms. | 3 months |
| Severity of CIPN: Tuning Fork Vibration Sensation Testing | A study-specific 128-Hz tuning fork will be used to assess vibration sensation on the great toe at baseline and 3 months. The time in seconds to loss of vibration sensation was measured. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN. The difference from baseline to 3 months in number of seconds to loss of vibration sensation was calculated for each patient. The differences were averaged across patients in each arm. The mean differences were compared between arms. | 3 months |
| Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments | Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted. | 3 months |
| Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months | Measured by patient-reported National Cancer Institute [NCI] Patient Reported Outcomes [PRO]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety. | 3 months |
| FG001 | Arm II (Cryotherapy) | Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Acupuncture, Acupressure, Cryotherapy) | Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies |
| BG001 | Arm II (Cryotherapy) | Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire | EORTC (European Organisation For Research And Treatment Of Cancer) CIPN (Chemotherapy-Induced Peripheral Neuropathy) 20 QOL (Quality of Life Questionnaire) patient reported outcomes questionnaire was used. 3 subscales all scored from 1 to 4: Sensory, Motor, and Autonomic. For all subscales: higher values represent a worse outcome. All subscales are to be reported separately. The raw scores are linearly converted to a 0-100 scale such that a higher score corresponds to a worse condition or more symptoms. | Mean | Standard Deviation | units on a scale |
|
| 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 | Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months | Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100. | Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study. | Posted | Mean | Full Range | units on a scale | At 3 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy | Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate. | Frequency of Chemotherapy-Induced Peripheral Neuropathy (CIPN) | Posted | Count of Participants | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure | The Neuropen is used to assess pressure perception. Pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot at each of the ten different sites recorded as present or absent. The proportion present was calculated for each patient at baseline and at 3 months. The difference between these proportions from baseline to 3 months was calculated for each patient. The mean of these differences was calculated within each arm and the difference of those means was then compared between arms. | Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study. | Posted | Mean | Standard Deviation | proportion of present responses | 3 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Severity of CIPN: Tuning Fork Vibration Sensation Testing | A study-specific 128-Hz tuning fork will be used to assess vibration sensation on the great toe at baseline and 3 months. The time in seconds to loss of vibration sensation was measured. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN. The difference from baseline to 3 months in number of seconds to loss of vibration sensation was calculated for each patient. The differences were averaged across patients in each arm. The mean differences were compared between arms. | Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study. | Posted | Mean | Standard Deviation | seconds | 3 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments | Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted. | Summary of Patient Adherence to Acupuncture Protocol Based on 60% Threshold | Posted | Count of Participants | Participants | 3 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months | Measured by patient-reported National Cancer Institute [NCI] Patient Reported Outcomes [PRO]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety. | Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
22 weeks
CTCAE vr. 5 terms used
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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 | Arm I (Acupuncture, Acupressure, Cryotherapy) | Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies | 5 | 33 | 0 | 33 | 18 | 33 |
| EG001 | Arm II (Cryotherapy) | Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies | 3 | 36 | 0 | 36 | 26 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oral Symptoms | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | Reported as Dry mouth; Mucositis oral; Oral pain; or Oral dysesthesia |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | Reported as Abdominal pain and Dyspepsia |
|
| Other Body Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | 1 or more Events reported as Back pain, Muscle cramp, Pain in extremity, Non-cardiac chest pain |
|
| Dysgeusia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blurred Vision | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Edema Limbs | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hot Flashes | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash Acneiform | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Other Surgical and Medical Procedures | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment | Any surgery or procedure completed |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Rectal Hemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| White Blood Cell Decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacey Cohen, MD | University of Washington Medical Center - Montlake | 2066066405 | sshovitz@fredhutch.org |
| Feb 27, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2022 | Feb 15, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001063 | Appendiceal Neoplasms |
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D005770 | Gastrointestinal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D001005 | Anus Neoplasms |
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012002 | Rectal Diseases |
| D001004 | Anus Diseases |
| D000236 | Adenoma |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D019050 | Acupressure |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Motor |
|
| Autonomic |
|
| Autonomic Subscale |
|
| Units | Counts |
|---|
| Participants |
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