Please select the eligibility criteria that correspond to the clinical trial below.
Title: RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial
Brief Summary: The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment parallel to radiation therapy in oncological patients. The trial is designed as a two-armed trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy, thereafter weekly until the end of radiotherapy; the follow-up visits include clinical workup as well as questionnaires.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed cancer in the pelvis
* Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy)

  * Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints)
  * Portions of rectum may have special blocking depending on disease site
  * Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy)
  * No planned split-course radiotherapy
  * No planned interstitial brachytherapy prior to completion of external-beam radiotherapy
  * Planned intracavitary radiotherapy allowed
  * No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin
  * Entered on study before the third radiotherapy fraction
* No current or prior metastases beyond pelvic or para-aortic lymph nodes
* No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy
* No incontinence of stool

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Renal:

* No chronic renal failure
* Creatinine less than 2 times upper limit of normal (for patients with history of renal disease)

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known allergy to octreotide
* No history of inflammatory bowel disease
* No other concurrent medical condition that would preclude study participation
* No history of cholecystitis unless prior cholecystectomy

PRIOR CONCURRENT THERAPY:

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy to the pelvis

Surgery:

* See Disease Characteristics
* No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum
B: Inclusion Criteria:

histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of \<15% calculated by the Yale-formula; Risk \[%\] = \[GS -5\] x \[PSA/3 + 1.5 x T\], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

* Karnofsky-Index ≥ 70%
* age between 40 and 80 years
* PSA

Exclusion Criteria:

Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
C: Inclusion Criteria:

* Histologically proven prostate cancer.
* Surgical candidate for prostatectomy.
* During study period, must agree not to take new supplements.
* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.
* Must give written and informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

During study period, must agree not to take new supplements.

* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
D: Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the trial:

* treatment with radiotherapy
* age ≥ 18 years of age
* Ability ability of subject to understand character and individual consequences of the clinical trial
* written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

Patients presenting with any of the following criteria will not be included in the trial:

* any contraindication to acupuncture
* known coagulopathy or anticoagulation therapy with bleeding time \> 4 minutes, thrombocyte count \< 50 000/μl
* missing compliance
* skin disease in the region of the acupuncture points
* refusal of the patients to take part in the study
* participation in another clinical study or observation period of competing trials,

Answer: D