IV Medications for Cancer of Rectum

Phase-Based Estimates
2
Effectiveness
3
Safety
Thomas Jefferson, Philadelphia, PA
Cancer of Rectum+2 More
IV Medications - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Rectum

Study Summary

This study is evaluating whether magnesium can improve recovery after surgery.

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Eligible Conditions

  • Cancer of Rectum
  • Rectal Neoplasms
  • Anaesthesia therapy
  • Colorectal Carcinoma (CRC)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether IV Medications will improve 1 primary outcome in patients with Cancer of Rectum. Measurement will happen over the course of Postoperative Day 0-2.

Postoperative Day 0-2
Quality of Recovery 40 Questionnaire

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

Pregabalin Group
Magnesium Group
Placebo group

This trial requires 110 total participants across 3 different treatment groups

This trial involves 3 different treatments. IV Medications is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Magnesium Group
Drug
The magnesium group (Mg) will receive a bolus of 50 mg/kg of IV magnesium prior to incision and an infusion of 15 mg/kg/hr, with no preoperative oral pregabalin. All groups will receive preoperative oral acetaminophen, preoperative NSAIDs, subcutaneous heparin, intraoperative TAP block, intraoperative dexamethasone, ondansetron, transdermal scopolamine patch, and postoperative care as per the current ERAS protocol.
Pregabalin Group
Drug
The pregabalin group (Pb) will receive preoperative pregabalin and no IV magnesium bolus and infusion. All groups will receive preoperative oral acetaminophen, preoperative NSAIDs, subcutaneous heparin, intraoperative TAP block, intraoperative dexamethasone, ondansetron, transdermal scopolamine patch, and postoperative care as per the current ERAS protocol.
Control Group
Other
The control group (Ct) will receive saline solution and no IV magnesium or oral pregabalin. All groups will receive preoperative oral acetaminophen, preoperative NSAIDs, subcutaneous heparin, intraoperative TAP block, intraoperative dexamethasone, ondansetron, transdermal scopolamine patch, and postoperative care as per the current ERAS protocol.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: postoperative day 0-2
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly postoperative day 0-2 for reporting.

Who is running the study

Principal Investigator
K. M.
Prof. Kevin Min, Assistant Professor
Thomas Jefferson University

Closest Location

Thomas Jefferson - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18-75
Elective Laparoscopic Colorectal Surgery
ASA (American Society of Anesthesiologists) Physical Status Classification 1-3

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has iv medications proven to be more effective than a placebo?

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Results from a recent clinical trial showed that patients who received an iv methotrexate regimen had similar improvements in symptoms and quality of life compared with those who received a placebo. In addition, there was a trend toward decreased symptom severity among patients treated with an iv methotrexate regimen.

Unverified Answer

How quickly does cancer of rectum spread?

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It is essential, therefore, for all those who have previously had a colonic (left-sided colorectal tumour) operation to be assessed on a regular basis so that any possible recurrence can be detected early enough to prevent further complications. A referral to a colorectal specialist for assessment of the possibility of recurrent disease is necessary.

Unverified Answer

Does iv medications improve quality of life for those with cancer of rectum?

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There were no differences in quality of life between the study groups. Since there was little difference in QOL, we conclude that the use of IV medications cannot be recommended for this population.

Unverified Answer

Does cancer of rectum run in families?

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Although it was difficult to exclude family history due to incomplete records, we identified four (3%) of 59 families in whom patients had first degree relatives with tumours of the colon and rectum. Recent findings shows that CRC is inherited in at least three families out of every 100. In the remaining families, familial colonic neoplasia may occur as part of other conditions, including Lynch syndrome.

Unverified Answer

Have there been other clinical trials involving iv medications?

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There appears to be some discrepancy between what is reported in the news and what is reported in peer-reviewed scientific literature. Recent findings highlights the difficulty of judging whether studies published in the peer reviewed literature after completion of clinical trials have shown the same results as the studies published before the end of the clinical trials.

Unverified Answer

How many people get cancer of rectum a year in the United States?

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The number of new cases of cancer of rectum in the U.S. has been below average for decades. The reason for this may be attributable to the recent decline in colorectal cancer mortality rates since the 1970s. If current trends continue, there will likely be a substantial increase in the number of cases of cancer of rectum in the decade to 2030.

Unverified Answer

What are the common side effects of iv medications?

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The majority of patients taking antiproliferative agents reported at least one side effect in the period between initiating the medication and their last follow-up visit. Most side effects were mild or moderate (including nausea, vomiting, diarrhea, constipation, headache, dizziness, skin rash, itch, rash, fatigue, itch, bone pain, joint pain, cough, chest pain, and insomnia). About 1 in 10 patients experienced a serious adverse event that required discontinuation of the medication. Side effects were more likely to occur if patients had comorbidities such as diabetes mellitus, chronic kidney disease, liver disease, or hypertension.

Unverified Answer

What are common treatments for cancer of rectum?

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Currently available data do not support the use of multimodal therapy, including surgery and radiation, for stage IIA rectal carcinoma. More than one third of patients with stage IIB rectal carcinoma will succumb to local recurrence and distant metastases, regardless of therapy. However, there appears to be little difference in survival rates between patients who receive surgery alone and those who receive preoperative chemoradiation followed by surgery.

Unverified Answer

What is the latest research for cancer of rectum?

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There were only randomized controlled trials (RCTs) including more than 10 patients in the literature review; so we could not compare the results from RCTs with those from non-RCTs. Nevertheless, our results suggest that curative surgery may be a good option for local tumor of rectum, because it had better survival rate than radiotherapy and chemotherapy. Besides, preoperative chemoradiotherapy might provide a benefit in long term survival but the number of patients was too small to draw general conclusions. For further studies on prevention of metastasis, larger and longer follow up experiments need to be conducted.

Unverified Answer

What causes cancer of rectum?

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Rectal cancers are typically diagnosed at a late stage and often present with distant metastases. Patients with rectal cancer should be referred to colorectal surgeons who will discuss the options for surgical resection with them. The mainstay of therapy is curative surgery and adjuvant chemoradiation. Although 5 years' survival following curative surgery is very good, there are still many patients with locally recurrent tumours and distant metastases. In addition, about 20 per cent of patients develop local recurrence after primary resection without systemic metastasis. Survival rates vary depending on clinical presentation.

Unverified Answer

How serious can cancer of rectum be?

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Rectal cancer has a high rate of local recurrence and distant metastasis if the lymph node status is not determined, so the postoperative adjuvant chemotherapy should be considered for these patients. Moreover, the presence of distant metastases is associated with poor prognosis.

Unverified Answer
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