RecruitingNCT04495790ACOSUpdated Feb 1, 2023

AIMS Cancer Outcomes Study

An observational study in Neoplasms, Neoplasm Malignant and Advanced Cancer, sponsored by Advanced Integrative Medical Science Institute. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Advanced Integrative Medical Science Institute · Observational

From the registry’s dates

Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
Started May 2020; still recruiting 6 years 4 months later.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 500
Sex: All

Study summary

The overall aim is to describe disease-free survival (DFS) in early stage cancer patients and three-year overall survival (OS) outcomes in advanced stage cancer patients receiving Advanced Integrative Oncology (AIO) treatment in a prospective consecutive case series outcomes study. We will collect data and study outcomes for patients with cancer who receive care at AIMS Institute.

Read the detailed description

It is estimated that between 50 and 80% of cancer patients in the United States (US) supplement their conventional medical treatment regimen with some form of complementary or alternative medicine (CAM) therapy or practice. A smaller percentage of these patients receive medical treatment from naturopathic doctors (NDs) who are board certified in naturopathic oncology (Fellows of the American Board of Naturopathic Oncology, FABNO) or have equivalent experience in caring for cancer patients. This level of care is being defined here as Advanced Integrative Oncology (AIO). AIO clinics provide comprehensive science- and experience-based naturopathic medical oncology integrated with the individual patient's conventional medical treatment.

Although there have been some studies of alternative and complementary medicine use by both adult and pediatric cancer patients, little is known about the effectiveness of naturopathic medicine provided to patients with cancer in an integrative setting. Increasing numbers of parents of children seek out naturopathic physicians and other integrative oncologists for evidence-based complementary integrative therapy that is coordinated with the child's standard oncology treatment plan. The AIMS Institute provides nutritional and botanical medicine care to children with leukemia, brain cancer, and osteosarcoma. Despite the widespread use of integrative oncology by children with cancer, little is known about the effectiveness of these therapies in pediatric cancer patients.

While there is scientific evidence supporting specific treatments that are commonly used, systematic study of their effectiveness, especially when used in combination as commonly recommended, is sparse. We believe that an early step in the evaluation of clinical outcomes associated with CAM is to take a health services approach and seek to answer the question: "Does exposure to AIO services improve the clinical outcomes of patients with cancer?"

Conditions studied

Neoplasms
Neoplasm Malignant
Advanced Cancer
Advanced Solid Tumor
Oncology

Browse trials for

Neoplasms 9,365

Keywords

Integrative Oncology
Naturopathic Oncology
Phytomedicine
Metabolic Therapy
Immunotherapy

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 500 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Advanced Integrative Medical Science Institute is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

All cancer patients who seek care at AIMS Institute and meet inclusion/exclusion criteria are eligible to participate in this study. Participants will be informed and educated about the prospective outcomes study by clinical staff as part of patient registration and the clinical intake process. Patients may be referred to AIMS Institute by cancer care centers, oncologists and other health care providers, or patients may be self-referred.

Inclusion criteria

A new patient coming in for a first office call (FOC) or first consultation via telemedicine with a diagnosis of cancer, or
An established patient with a diagnosis of cancer receiving treatment at the AIMS Institute;
If over 18 years of age are able to understand study design adequately and provide signed informed consent (IC) to enrollment;
If younger than 18 years of age informed assent from the child and informed consent from a parent or guardian who is able to understand the study design adequately and provide signed informed consent for the pediatric patient;
A confirmed diagnosis of cancer based on medical oncology medical records.

Exclusion criteria

Exclusion Criteria:

Patients not diagnosed with cancer;
Telehealth patients;
Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires;
Unwilling to participate in the AIMS Institute observational study.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 500 participants (estimated)
Target follow-up: 5 Years
Patient registry: Yes

What researchers measure

Primary outcomes

AIM 1 (survival)
Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute.
Time frame: 5 Years

Secondary outcomes

AIM 2 (treatment)
Describe AIO treatments prescribed and provided by AIMS physician and their medical staff.
Time frame: 5 Years
AIM 3 (correlate survival with treatment)
Correlate survival outcomes with treatments received.
Time frame: 5 Years

Study locations

1 of 1 sites recruiting

AIMS Institute
Seattle, Washington 98102, United States
- Michelle Speaks, MBA · Contact · mspeaks@aimsinstitute.net · 2064201321
- Sunil K Aggarwal, MD, PhD, FAAPMR · Contact · saggarwal@aimsinstitute.net · 2064201321
- Therry Eparwa, DNP, ARNP, FNP-BC · Principal investigator
- Leanna J Standish, ND, PhD, Lac, FABNO · Sub investigator
- Sunil K Aggarwal, MD, PhD, FAAPMR · Sub investigator
- Sonia S Malani, ND · Sub investigator
Recruiting

References and documents

Publications

Ladas EJ. Integrative Medicine in Childhood Cancer. J Altern Complement Med. 2018 Sep/Oct;24(9-10):910-915. doi: 10.1089/acm.2018.0224. PubMed 30247963 ↗
Neuhouser ML, Patterson RE, Schwartz SM, Hedderson MM, Bowen DJ, Standish LJ. Use of alternative medicine by children with cancer in Washington state. Prev Med. 2001 Nov;33(5):347-54. doi: 10.1006/pmed.2001.0911. PubMed 11676573 ↗
Ghiasuddin A, Wong J, Siu AM. Complementary and alternative medicine practices, traditional healing practices, and cultural competency in pediatric oncology in Hawai' i. J Integr Med. 2016 Sep;14(5):374-9. doi: 10.1016/S2095-4964(16)60267-6. PubMed 27641608 ↗
Lerman C, Trock B, Rimer BK, Jepson C, Brody D, Boyce A. Psychological side effects of breast cancer screening. Health Psychol. 1991;10(4):259-67. doi: 10.1037//0278-6133.10.4.259. PubMed 1915212 ↗
McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004. PubMed 8277801 ↗
Seely D, Wu P, Fritz H, Kennedy DA, Tsui T, Seely AJ, Mills E. Melatonin as adjuvant cancer care with and without chemotherapy: a systematic review and meta-analysis of randomized trials. Integr Cancer Ther. 2012 Dec;11(4):293-303. doi: 10.1177/1534735411425484. Epub 2011 Oct 21. PubMed 22019490 ↗
Ma Y, Chapman J, Levine M, Polireddy K, Drisko J, Chen Q. High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. Sci Transl Med. 2014 Feb 5;6(222):222ra18. doi: 10.1126/scitranslmed.3007154. PubMed 24500406 ↗
McCulloch M, Broffman M, van der Laan M, Hubbard A, Kushi L, Abrams DI, Gao J, Colford JM Jr. Colon cancer survival with herbal medicine and vitamins combined with standard therapy in a whole-systems approach: ten-year follow-up data analyzed with marginal structural models and propensity score methods. Integr Cancer Ther. 2011 Sep;10(3):240-59. doi: 10.1177/1534735411406539. Epub 2011 Sep 30. PubMed 21964510 ↗
Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819. PubMed 17557947 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04495790
Lead sponsor: Advanced Integrative Medical Science Institute
Responsible party: Sponsor
First posted: Aug 3, 2020
Start date: May 18, 2020
Primary completion: May 18, 2025 (estimated)
Completion: Dec 31, 2030 (estimated)
Last update: Feb 1, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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