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A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II

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.

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

- Patients on adjuvant hormone therapy for less than 1 month

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in quality of life over 16 weeks

Outcome Description:

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.

Outcome Time Frame:

Baseline, End of week 8, End of week 16

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

August 2014

Related Keywords:

  • Breast Cancer
  • Breast, Cancer, Survivorship, Integrative, Complementary
  • Breast Neoplasms



University of California, San Francisco, Osher Center for Integrative Medicine San Francisco, California  94115