Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of a Progressive Resistance Training in Cachectic Cancer Patients During Radiotherapy - a Randomized Controlled Pilot Trial
Brief Summary: Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purpose of this study was to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy in a pilot randomized controlled design.

Baseline data for all participants were ascertained via medical records and patient interview. This included demographic information, Union internationale contre le cancer-status (UICC-status), comorbidities and the results of blood samples. Outcomes were measured at admission. One study coordinator completed all assessments to enhance patient compliance. Body weight loss percentage was calculated via the individuals' body weight 6 months before (in retrospect) and the current body weight. Participants completed two questionnaires: The Multidimensional Fatigue Inventory and the Functional Assessment of Anorexia/Cachexia Therapy questionnaire. Six-Minute Walk Test was applied. To document changes in muscle force, strength of the functional muscle group for elbow flexion in supine position as well as of knee extension in sitting position (in each case right and left) was tested via hand-held dynamometry for isometric maximal muscle strength. Bioelectrical impedance analysis was executed to assess the adaption in body composition.

The exercise intervention was undertaken in the hospitals department of physical and rehabilitation medicine and based on standardized but individualized training protocols. It consisted of a warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets.


Options:
A: Inclusion Criteria:

* Women without lymphedema must be 1-5 years post breast cancer diagnosis
* Women with lymphedema must be 1-15 years post breast cancer diagnosis
* Women with lymphedema must have stable lymphedema. ONE of the following:

  * 0-40\>10% girth volume difference between the affected and non- affected limb for a non-dominant arm
  * 6-40% girth volume difference between the affected and non- affected limb for a dominant arm inter-limb discrepancy in volume or circumference at the point of greatest visible difference OR swelling or obscuration of anatomic architecture upon close inspection OR pitting edema.

    * 2 cm circumference difference
  * A prior clinical diagnosis of lymphedema and having had any prior intensive lymphedema therapy on the affected arm

As well as ALL of the following four conditions:

* Women with Lymphedema must have ALL of the following:

  * No recorded arm girth change of 15% or greater within the three months.
  * No more than one lymphedema related infection requiring antibiotics within the past 3 months.
  * Participation in all Activities of Daily Living (ADLs) without lymphedema exacerbation for the past 3 months.

Exclusion Criteria:

* For ALL participants (with and without lymphedema)

  * No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
  * Not morbidly obese (body mass index \>50 kg/m2)
  * No plans for additional (e.g. reconstructive) surgery during the study period
  * No bilateral breast cancers (because this prohibits our ability to assess the primary outcome of interest)
  * No strength training or other upper body resistive exercise within the past year
  * Not planning to move away from the area over the next year
  * Not pregnant or lactating or planning to become pregnant during the study
  * Among women who have given birth: at least 6 months post pregnancy and at least 3 months post lactation
B: Inclusion Criteria:

* planned inpatient or outpatient radiotherapy
* ≥ 18 years of age
* diagnosed state of cachexia (weight loss greater than 5 % over the past 6 months) or pre-cachexia (unintentional weight loss of 5 % or less of usual body weight during the last 6 months)

Exclusion Criteria:

* metastatic disease
* severe neurological problems or other contraindications for resistance training
C: Inclusion Criteria:

* Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are currently taking aromatase inhibitors or selective estrogen receptor modulators for the next 8 months.
* English speaking
* Medical clearance for participation provided by primary care physicians
* If the patient has undergone a surgical procedure, must be at least 6 weeks post-procedure

Exclusion Criteria:

* Diagnosis of dementia or organic brain syndrome
* Medical, psychological or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.)
* Contraindication to participation in a regular physical activity program.
* Metastatic or recurrent disease
* Inability to ambulate
* Engaged in \>/= 60 minutes of vigorous physical activity or \>/= 150 minutes of moderate plus vigorous physical activity per week during the past month.
D: Inclusion Criteria:

* Histological proven cancer in one or more of the following areas: larynx, hypopharynx, oropharynx, cavi oris, or unknown primary tumor
* Set to curative radiotherapy with or without concurrent chemotherapy for treatment of cancer in the head and neck region in accordance with the Danish Head and Neck Cancer Group (DAHANCA) guidelines
* Fully self-reliant
* Danish skills, oral and written
* Informed consent

Exclusion Criteria:

* Previously received treatment for head and neck cancer (radiotherapy, chemotherapy and/or surgery).
* Pregnancy
* ECOG performance status \> 2
* Presence of psychological-, family-, sociological- or geographical issues that could prevent the patient from completing the intervention
* Simultaneous or previous illness or conditions that could prevent the patient's ability to complete the intervention.

Answer: B