Integrative Approaches for Cancer Survivorship (IACS)
The purpose of this study is to determine whether a four-month manualized Ayurvedic intervention will improve quality of life in recent breast cancer survivors.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II|
- Change in quality of life over 16 weeks [ Time Frame: Baseline, End of week 8, End of week 16 ] [ Designated as safety issue: No ]The investigators will use the EORTC QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) 68 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|Experimental: Ayurvedic Intervention||
Behavioral: Individualized manualized Ayurvedic intervention
The manualized intervention will begin with an initial clinic visit (approximately 90 minutes) with the Ayurvedic practitioner in which the patient's diagnosis will be determined, an overview of Ayurveda will be given, and the initial treatment will be recommended based on the Ayurvedic diagnosis. Follow-up visits will range between 30 and 60 minutes in duration. The treatment modalities employed in the study will include nutrition, lifestyle, yoga, and marma (a treatment similar to acupressure).
Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. We aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, we aim to develop the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488123
|United States, California|
|University of California, San Francisco, Osher Center for Integrative Medicine||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Amisha Vadodaria 415-353-7728 VadodariaA@ocim.ucsf.edu|
|Principal Investigator: Anand Dhruva, MD|