Clinical trial NCT05743023: Consciousness-based Ayurveda Lifestyle Program for Improving Quality of Life in Survivors of Breast Cancer
Official title: Evaluation of an Ayurvedic Whole Systems-based Lifestyle Protocol for Quality of Breast Cancer Survivorship: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Survivors
Keywords: Breast cancer
Breast cancer survivorship
Ayurveda
Lifestyle
Integrative
Mind-body medicine
Lead sponsor: Maharishi International University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a pilot study to assess the feasibility and effectiveness of a 12-week intervention of personalized diet and lifestyle protocol based on the principles of Ayurveda's whole systems approach to achieving improvement in a) quality of life, b) digestive health, c) sleep among women breast cancer survivors.

Detailed description: Breast cancer is the most common cancer among women worldwide. Due to advancements in early diagnosis and treatment, the survival rate of breast cancer has significantly increased. According to the National Cancer Institute's office of cancer survivorship, as of January 2019, there are 3.8 million breast cancer survivors.

Evidence indicates that cancer survivors experience many adverse effects of treatment and suffer from significant quality of life (QOL) challenges such as depression, anxiety, emotional, social, psychological, physiological, and spiritual wellbeing.

Personalized diet, lifestyle and daily routine approaches to breast cancer survivorship are often undervalued. Generally, the dietary guidelines are based only on an individual's nutritional and caloric needs.

Due to the increasing number of breast cancer survivors, it has become essential to have evidence-based guidelines for breast cancer survivorship to improve digestive health, QOL, and general wellbeing. Understanding the science behind personalized lifestyle-related factors, including diet, exercise, and emotional and spiritual wellbeing in cancer survivorship, is urgently needed. Digestive health and the gut microbiome may play an important role in the QOL after surviving breast cancer; however, there are fewer studies on the relationship between diet and daily routine to gut health and breast cancer survivorship care.

This study will test whether personalized guidelines based on the principles of Maharishi Ayurveda - a whole systems approach to reducing strength, improving digestive health and living in harmony with the circadian rhythm to improve QOL for women diagnosed and treated for breast cancer. In addition to that, this pilot study may provide preliminary data to further develop a clinical practice guideline that is cost-effective and easy to follow for women breast cancer survivors.

Eligibility criteria: Inclusion Criteria:

* A breast cancer survivor in remission (Females ≥ 18 years)
* Diagnosis of stage I-IV breast cancer
* Three months or more after receiving conventional treatment (chemotherapy, radiation therapy, and/or surgery)
* Willing to comply with the study intervention recommendations for 12 weeks
* English speaking
* Have access to technology to participate in zoom visits

Exclusion Criteria:

* Male responders
* Inability to provide informed consent
* Physiological or psychological debility that would interfere with the ability to participate in the study fully
* Active metastatic or recurrent disease (to avoid early withdrawal from the study)
* Anticipates undergoing surgery during the duration of the intervention
* Substance abuse (to avoid early withdrawal from the study)

Primary outcomes:
measure: Change in Quality of life
timeFrame: 0, 6 weeks, and 12 weeks
measure: Change in Digestive health
timeFrame: 0, 6 weeks, and 12 weeks
measure: Change in Sleep disturbance
timeFrame: 0, 6 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Maharishi International University
state: California
Study officials:
affiliation: Maharishi International University, Fairfield, Iowa
name: Robert Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: