Integrative Approaches For Cancer Survivorship 2: Project 1



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:September 2016
End Date:September 21, 2018

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Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship

The purpose of this study is to develop and test a 12-month Integrative Medicine intervention
based on Ayurvedic medicine in recent breast cancer survivors.

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. The investigators aim to
perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast
cancer survivors with impaired quality of life. Specifically, the investigators aim to refine
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 24 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 complete remission

- Aged 18 years or older

- Able to read, write, and understand English

- Karnofsky Performance Status (KPS) greater than or equal to 60

- Have impaired quality of life

- Ability to give informed consent

Exclusion Criteria:

- Having received Ayurvedic treatment within 6 months of study enrollment

- Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2
directed 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 2 months

- Have surgery for breast cancer or breast reconstructive surgery planned during the
initial 6 month study period. Smaller surgical procedures such as implant exchange are
not exclusionary.
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