Clinical trial NCT02897635: Integrative Approaches For Cancer Survivorship 2: Project 1
Official title: Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-09-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life over 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in fatigue over 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in sleep quality over 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in anxiety over 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in depressive symptoms over 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in pain over 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in diet over 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anand Dhruva, MD
role: PRINCIPAL_INVESTIGATOR
References: