Please select the eligibility criteria that correspond to the clinical trial below.
Title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Brief Summary: RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.


Options:
A: Inclusion Criteria:

* Female
* Cancer diagnosis
* Postmenopausal

Exclusion Criteria:

* Health condition contraindication to moderate physical activity
B: Inclusion Criteria:

* breast cancer survivor
* overweight or obese (BMI of 25 or greater)
* must have breast cancer related lymphedema
* at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
* the eligible age range will have no lower limit.
* currently free of cancer

Exclusion Criteria:

* medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
* inability to walk for 6 minutes unaided
* extremely obese (body mass index greater or equal to 50 kg/m2)
* plans for additional (e.g. curative or reconstructive) surgery during the study period
* self-report of weight-lifting within the past year
* already engaging in 3 or more times weekly aerobic activity of moderate intensity
* planning to move away from the area over the next year
* current use of weight loss medication (OTC or prescription)
* self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)
* weight loss of greater than 10 % in the past 3 months
* history of bariatric surgery
* women who are pregnant
C: DISEASE CHARACTERISTICS:

* Stage 0-IIIA breast cancer survivor
* Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)

  * At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last
* Women who are not currently practicing yoga and have not participated in any of the following activities:

  * Meditation, tai chi, or related activities
  * Yoga or tai chi within the past 6 months
  * Had classes for or practiced yoga for more than 3 months
* Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible
* No inflammatory breast cancer

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of \< 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
* Physically able to fully participate in yoga intervention

Exclusion criteria:

* Inability to comfortably get up and down from the floor 2-3 times in a session
* Breathing problems requiring use of oxygen
* Problems walking without a cane or walker assistance
* Prior knee or hip replacement with limited movement in the joint
* Inability to comfortably lie on the stomach
* Alcohol, or drug abuse
* Diagnosis of any of the following conditions:

  * Diabetes
  * Chronic obstructive pulmonary disease
  * Uncontrolled hypertension
  * Evidence of liver or kidney failure
  * Symptomatic ischemic heart disease
  * Significant visual or auditory problems
  * Mental disorder or cognitive impairment
  * Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)
  * Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis
* History of breast or any other cancer, except basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No regular use of medications with major immunological consequences (e.g., steroids)
D: DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer
* Completely resected disease

  * No clinically detectable residual loco-regional axillary disease
  * Prior surgery for primary breast cancer of 1 of the following types:

    * Total mastectomy with or without adjuvant radiotherapy
    * Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative\* for invasive disease and ductal carcinoma in situ) with planned radiotherapy NOTE: \*If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed
* Tumor confined to the breast and axillary nodes

  * Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed
* Axillary lymph node dissection or a negative axillary sentinel node biopsy required

  * Patients with negative or microscopically positive axillary sentinel nodes are eligible
  * Positive sentinel nodes must have either axillary dissection or radiation of axillary nodes
* No distant metastases
* No locally advanced inoperable breast cancer, including any of the following:

  * Inflammatory breast cancer
  * Supraclavicular node involvement
  * Enlarged internal mammary nodes (unless pathologically negative)
* Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria
* No prior ipsilateral or contralateral invasive breast cancer
* Hormone receptor status:

  * Estrogen and/or progesterone receptor positive

    * At least 10% of the tumor cells positive by immunohistochemistry
    * If \> 1 breast tumor, each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

Age

* Premenopausal

Sex

* Female

Menopausal status

* Premenopausal

  * Estradiol in the premenopausal range after prior surgery OR meets the following criteria:

    * Menstruating regularly for the past 6 months
    * Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* No systemic hepatic disease that would preclude prolonged follow-up

Renal

* No systemic renal disease that would preclude prolonged follow-up

Cardiovascular

* No systemic cardiovascular disease that would preclude prolonged follow-up
* No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable

Pulmonary

* No systemic pulmonary disease that would preclude prolonged follow-up

Other

* Not pregnant or nursing
* Fertile patients must use effective nonhormonal contraception
* No history of noncompliance to medical regimens
* No other nonmalignant systemic disease that would preclude prolonged follow-up
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:

  * Stage I papillary thyroid cancer
  * Stage IA carcinoma of the cervix
  * Stage IA or B endometrioid endometrial cancer
  * Borderline or stage I ovarian cancer
* No psychiatric, addictive, or other disorder that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed

Chemotherapy

* No prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

* No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis
* No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
* No concurrent oral or transdermal hormonal therapy
* No other concurrent estrogen, progesterone, or androgens
* No other concurrent aromatase inhibitors
* No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)

Radiotherapy

* See Disease Characteristics
* No prior ovarian radiotherapy

Surgery

* See Disease Characteristics
* No prior bilateral oophorectomy

Other

* No concurrent bisphosphonates, except in the following cases:

  * Bone density is at least 1.5 standard deviations below the young adult normal mean
  * Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting
* No other concurrent investigational agents

Answer: C