Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment individualized manualized ayurvedic intervention
Sponsor University of California, San Francisco
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date January 2012
End date August 2014
Trial size 40 participants
Trial identifier NCT01488123, 5K23AT005340-03, A112313

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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).

Primary Outcomes

Measure
Change in quality of life over 16 weeks
time frame: Baseline, End of week 8, End of week 16

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female breast cancer survivor who is over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) - Having received chemotherapy as part of their primary therapy for breast cancer - Be in a complete remission - Aged 18 years or older - Able to read, write, and understand English - Karnofsky Performance Status (KPS) 67 greater than 60. - Ability to give informed consent Exclusion Criteria: - Having received Ayurvedic treatment within 2 months of study enrollment - Receiving chemotherapy or radiotherapy at the time of study enrollment. Trastuzumab therapy is not exclusionary. - Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary. - Patients on adjuvant hormone therapy for less than 1 month

Additional Information

Official title A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.