Integrative Approaches for Cancer Survivorship
This trial is active, not recruiting.
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Change in quality of life over 16 weeks
time frame: Baseline, End of week 8, End of week 16
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
|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.|
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