Neoplasms

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Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

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Herbal and Botanical

Oxaliplatin

Cola

Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy

20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life

Questionnaires

Xin Shelley Wang, MD. MPH

The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.

If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled visit. The questionnaires are designed to measure pain and other symptoms, your mood, and your quality of life.

You will also give a tissue sample by inserting a cotton tipped swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about 1 minute at the most.

Completing the 5 questionnaires and the swab sample should take about 30 minutes.

Length of Study:

After you complete the questionnaires and the swab sample collection, your active participation in this study will be over.

This is an investigational study.

Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.

Serum and cell samples will also be collected during chemotherapy for analysis of cytokines and their relationship to symptom production.

Longitudinal Study of Symptoms in Colorectal Cancer

Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer

AstraZeneca

M.D. Anderson Cancer Center

Symptoms and General Pathology

Inflammation

Other Dietary Supplements

Omega 3 Fatty Acid

Single arm study: Omega-3 enriched fruit juice in increasing dosage

Different doses of omega-3 will be administered to five different groups:

400, 800, 1200, 2400 and 3000 mg/m2.

Omega-3 enriched fruit juice

Per Kogner, Professor

The purpose of this study is to find an optimal dose of omega-3 that can be given to children who have completed cancer therapy. The future aim is to add omega-3 to conventional cancer treatment modalities and thereby hopefully increase the treatment efficacy, which will have to be addressed in subsequent phase-2 studies.

The rationale for this phase-1 trial is to find an appropriate dose of omega-3 for future phase-2 studies. The investigators aim at defining a dose that can safely be given to children previously treated for cancer, and that does not cause unacceptable side effects. In a longer perspective, randomized control trials are planned where the supplement is given for longer periods of time, and in combination with conventional cancer treatment. In preparation for these trials, this dose finding study was designed that also evaluates compliance. Subsequently the investigators hope that this supplementation can be beneficial for children during both cancer treatment and after remission.

The study population consists of children judged to be in complete clinical remission from cancer. In a phase 1 trial, one usually uses healthy individuals as study subjects, but in pediatric studies this is not allowed. Therefore patients who are in full remission were chosen as study objects, but who still come to the clinic for regular follow-ups. This group of patients is relevant for this study since it represents all ages and base-line diets, all kinds of childhood cancers, and because they have suffered from cancer and in many cases still live with the severe consequences of it.

The study is designed to give five groups of eight individuals each different doses of omega-3 adjusted to body surface area. The first group starts out on a dose of omega-3 fatty acids that is similar to the generally recommended daily intake for adults (200-400 mg). A dose escalation is then done performed group wise. The highest possible dose in this study (2 x 3000mg/day at dose level 3000 mg/m2 to a child at 1.55 m2, 3871 mg/m2) is still lower than what has previously been given as maximum to children in other studies. The investigators will keep escalating the dose level within the study only as long as no unacceptable side effects are reported.

The administration is done orally by drinking 200 mL of omega-3 supplemented fruit juice daily. It has a good fruity taste, low amounts of sugar, and no fish flavour. This should facilitate treatment compliance for the children in particular compared to when omega-3 is given in capsules - the commonest choice in other studies, but less suitable for children. Compliance is important and not further jeopardized by trying to divide the fruit juice in less amounts than the whole package, but the individually prescribed dose as well as the actual amount ingested will be recorded and exact calculations used in the analysis of the study.

All study results are primarily evaluated on an intention-to-treat basis, but will also be calculated as treated per protocol and further calculated on the exact dose consumed over 90 days given the compliance in terms of consumed number of fruit juice packages.

OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer

OmegaChild - Omega-3 Supplementation to Children Now in Full Remission From a Previous Cancer; an Early Phase Dose-finding Study.

Compliance is calculated in percentage (%) using the number of fruit juice packages actually consumed (according to patient diary and interview) / number of packages prescribed (one or two daily pending dose level and body surface area).

Omega-3 index is defined as % of DHA + EPA of total fatty acids in erythrocyte membranes.

(DHA: Docosahexaenoic acid. EPA: Eicosapentaenoic acid).

Adverse events will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Longitudinal Study of Symptoms in Colorectal Cancer	NCT00777192	Colorectal Canc...	Questionnaires	18 Years -	M.D. Anderson Cancer Center
OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer	NCT02134600	Pediatric Cance...	Omega-3 enriche...	2 Years - 18 Years	Karolinska Institutet
Longitudinal Study of Symptoms in Colorectal Cancer	NCT00777192	Colorectal Canc...	Questionnaires	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for neuropsychiatric symptoms