Integrative Approaches For Cancer Survivorship 2: Project 1

Breast Cancer Clinical Trial

— IACS2  

Official title:

Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897635
• Other study ID #: 16-18567
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 21, 2018

Study information

• Verified date: March 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 21, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Individualized Integrative Medicine Intervention

Locations

Country	Name	City	State
United States	University of California, San Francisco, Osher Center for Integrative Medicine	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life over 12 months	The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a Breast Cancer-Specific Subscale (BR23) to collect data on qualify of life and cancer-related symptoms.	Baseline, 3 months, 6 months, 12 months
Secondary	Change in fatigue over 12 months	The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.	Baseline, 3 months, 6 months, 12 months
Secondary	Change in sleep quality over 12 months	The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.	Baseline, 3 months, 6 months, 12 months
Secondary	Change in anxiety over 12 months	The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.	Baseline, 3 months, 6 months, 12 months
Secondary	Change in depressive symptoms over 12 months	The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.	Baseline, 3 months, 6 months, 12 months
Secondary	Change in pain over 12 months	The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.	Baseline, 3 months, 6 months, 12 months
Secondary	Change in diet over 12 months	The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.	Baseline, 3 months, 6 months, 12 months