Integrative Approaches for Cancer Survivorship (IACS)

University of California San Francisco (UCSF)

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Individualized manualized Ayurvedic intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01488123

A112313

5K23AT005340-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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